Low FODMAP diet improves leaky gut in study

In a study, patients with irritable bowel syndrome with diarrhea, or IBS-D, who went on a low FODMAP diet saw an improvement of colonic barrier dysfunction, commonly known as “leaky gut.”

The results, published in Gastroenterology, represent the first evidence of low FODMAP’s potential ability to improve intestinal permeability and mast cell activation in patients with IBS.

“Diet and microbiome have been believed to be related to leaky gut, but the reasons why were not well understood,” said Prashant Singh, MBBS, Michigan Medicine gastroenterologist and senior author on the paper.

“This research illuminates the mechanism of how food can interact with gut microbiome and gut immune system to influence colonic barrier dysfunction—and validates the low FODMAP diet as a treatment option that not only improves symptoms but underlying dysfunction in IBS.”

The low FODMAP diet is a proven intervention for patients with IBS.

Most IBS sufferers report food-triggered symptoms and prefer dietary inventions to pharmacotherapy.

Leaky gut refers to symptoms caused by increased permeability of the intestinal lining.

This permeability is thought to have a variety of negative consequences, including the dissemination of bacterial toxins and products as well as sensitization of local nerves which can cause pain in IBS.

Researchers studied human patients to test the potential of low FODMAP to address leaky gut, while mice treated with stool from these patients were used to investigate the mechanisms of how diet potentially improves the colonic barrier.

Forty-eight patients with IBS-D (irritable bowel syndrome with diarrhea) were put on a four-week low FODMAP diet (restriction phase) and provided with the low FODMAP meals for the study duration.

Of the 42 participants to complete the study, 34 responded to the low FODMAP diet, all of whom experienced lessened diarrhea and abdominal pain.

Prior studies have shown that patients with IBS-D have increased number of mast cell (type of inflammatory cell in colon lining), and leaky gut.

Studies have shown that mast cells are also more likely to be activated in IBS-D.

In this study, barrier function, and mast cell activation was assessed in a variety of ways before and after the four-week period.

Researchers found that in addition to improvement in leaky gut, low FODMAP also reduced the number and activation of mast cells in the colon lining in these patients.

Researchers also worked toward an explanation of how low FODMAP improves leaky gut (and how a diet high in FODMAP foods can contribute to barrier dysfunction.)

Lipopolysaccharides are molecules derived from gut microbiome that can cause immune-system responses when they escape the gut.

In this latest study, an analysis using mice, researchers showed that high FODMAP diet in IBS-D patients increases fecal LPS levels to activate mast cells which in turn make the barrier leakier.

Given these results, researchers recommend that providers consider mast cell stabilizers in addition to a low FODMAP diet-or as an alternative to the low FODMAP diet when it is contraindicated.

“Our study shows diet is not a quick fix-it’s a real solution for some patients with IBS,” Singh said.

The authors hope future studies will include a larger sample size, specifically of patients who do not respond to low FODMAP diet, and a variety of IBS types besides IBS-D.

Reference:

Gao, Jun, Low FODMAP diet improves colonic barrier function and mast cell activation in patients with IBS-D: A mechanistic trial, Gastroenterology. 

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Ajanta Pharma Gets Relief in Erectile Dysfunction Drug Export Case, Penalty Set Aside

Mumbai: In relief to Ajanta Pharma Ltd, the Customs, Excise & Service Tax Appellate Tribunal (CESTAT), Mumbai has set aside a Rs 2 lakh penalty imposed on the company in connection with the alleged misdeclaration of exported erectile dysfunction drugs including Kamagra Oral Jelly, Super Kamagra Tablets, and Kamagra Gold Tablets.

The matter relates to 43 consignments exported between September 11, 2018, and March 10, 2021, which included Kamagra Oral Jelly, Super Kamagra Tablets, and Kamagra Gold Tablets. Although the shipping bills, invoices, and packing lists carried correct descriptions of the goods, the corresponding airway bills were marked as “medical apparatus.” The customs department treated this as misdeclaration under Para 2.06(a) of Chapter 2 of the Foreign Trade Policy 2015-20 and DGFT notification dated 12.03.2015, imposing a penalty under Section 117 of the Customs Act.

Ajanta Pharma challenged this decision before the Tribunal. During the hearing, Dr Suvendu Kumar Pati, Member (Judicial), observed:

“Section 117 is restricted to imposition of penalties for contravention of provisions of Customs Act only or for its abetment… No such violation is noticeable here.”

The Tribunal noted that the Customs authorities themselves admitted that the shipping documents bore accurate product descriptions, and only the airway bills – a document handled by freight forwarding agents – carried the alternate terminology. The show cause notice and the Order-in-Original were based on provisions from the Foreign Trade Policy, but no direct violation of the Customs Act was alleged or proven.

The CESTAT also referred to the Supreme Court’s ruling in M/s. Amrit Foods Vs. Commissioner of Central Excise (2005 (190) ELT 433 SC), which underscores that penalty cannot be sustained without the assessee being informed of the exact nature of the contravention.

Based on these findings, the Tribunal ruled;

“I am of the considered view that no provision of the Customs Act has been violated nor even alleged to have been violated by the Appellant-Exporter, for which it can be made liable to penalty under Section 117 of the Customs Act, 1962.”

Subsequently, the appeal was allowed, and the penalty order issued by the Commissioner of Customs (Appeals), Mumbai-III vide Order-in-Appeal No. MUM-CUSTM-AXP-APP-886/2022-23 dated 24.08.2022 was set aside, granting consequential relief to Ajanta Pharma.

To view the original judgment, click on the link below:

https://indiankanoon.org/doc/36778581/

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NPPA Panel Defers Biological E’s Pneumonia Vaccine Price Exemption, Seeks Clarification

New Delhi: The National Pharmaceutical Pricing Authority (NPPA)’s Multidisciplinary Committee of Experts has asked Biological E Limited to submit inputs and clarifications regarding the composition of its Pneumococcal Polysaccharide Conjugate Vaccine ((PNEUBEVAX 14), before it decides on the company’s application for exemption under Para 32 (i, ii & iii) of the DPCO, 2013.

The matter was taken up during the 69th meeting of the Multidisciplinary Committee held on July 3, 2025, chaired by Shri Sanjay Kumar, Advisor (Cost). It had previously been listed in the 64th, 66th, and 67th meetings, but was deferred each time pending comments from the Department for Promotion of Industry and Internal Trade (DPIIT).

As recorded in the minutes, “the matter was earlier placed in 64th meeting of MDC held on 6.12.2024, wherein the agenda was deferred and the committee directed that the matter may be pursued with DPIIT for nomination of suitable officer.” A DPIIT representative eventually attended the 66th meeting and informed the Committee that “the subject application as forwarded by NPPA is at an advanced stage of examination.”

However, in the 67th meeting held on 02.04.2025, “neither any comments have been received nor the meeting was attended by representative of DPIIT. Accordingly, the Committee deferred the agenda and directed to pursue the matter with DPIIT for early inputs in the matter.”

At the 69th meeting, an officer from DPIIT provided written inputs. As per the minutes:

“It has been also informed that in claim 1 submitted to the patent office, strength of each serotype is not mentioned. However, the strengths are mentioned in claim 6 submitted to the patent office.”

Additionally, “O/o CGPDTM has highlighted that strength of each serotype is different in granted claim 6 and composition mentioned in application filed to NPPA. The applicant mentioned the strength in application filed to NPPA as per DCGI approval.”

It was further noted that:

“O/o CGPDTM has also informed that ‘it is observed that the composition as specified in Row 4 of Form-1 dated 21/04/2023 and the claims granted by Indian Patent Office in this matter are almost equivalent when the granted claim 1 is read with claim 6.’”

In light of these submissions, the Committee stated:

“Accordingly, the Committee after deliberations directed to get the inputs/clarification of the applicant company in view of inputs of the DPIIT before final taking the final decision in the matter.”

Biological E’s application pertains to its patented vaccine product PNEUBEVAX 14 and requests exemption from price control under Para 32 of the Drugs (Prices Control) Order, 2013, which allows such exemptions for new patented drugs.

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Twin Challenges: Study Investigating the Co-Development of Perinatal Insomnia and Depression

Recent study examined the heterogeneous progression, interrelationships, and predictive factors of perinatal insomnia and depression across the perinatal period. The researchers used group-based trajectory modeling to identify distinct trajectories of insomnia and depressive symptoms from early pregnancy to 6 months postpartum.

Distinct Trajectories of Insomnia and Depression

The results showed three distinct insomnia trajectories: a “no insomnia” group (27.7%), a “subclinical insomnia” group (54.5%), and a “clinical insomnia” group (17.8%). For depressive symptoms, three trajectories were also identified: a “low-stable” group (38.7%), a “moderate-stable” group (43.9%), and a “high-improving” group.

Interrelationships Between Insomnia and Depression

The dual trajectory analysis revealed significant interrelationships between insomnia and depression, with the severity of symptoms co-occurring. Women in the low-stable depression group predominantly had no insomnia, while those in the moderate-stable depression group mostly had subclinical insomnia, and the high-improving depression group had the highest rates of clinical insomnia.

Predictive Factors for Insomnia and Depression Trajectories

Baseline factors including anxiety scores ≥24, insomnia scores ≥8, and depression scores ≥10 were common predictors of both adverse insomnia and depression trajectories. However, social capital was not a significant predictor.

Implications and Recommendations for Integrated Interventions

These findings highlight the importance of integrated screening and treatment approaches that simultaneously address comorbid insomnia and depression during the perinatal period. Tailored interventions based on symptom trajectory profiles could help improve maternal mental health outcomes. Future research should further explore the temporal dynamics and underlying mechanisms linking these conditions.

Key Points

1. The study examined the heterogeneous progression, interrelationships, and predictive factors of perinatal insomnia and depression across the perinatal period using group-based trajectory modeling.

2. The results showed three distinct trajectories for both insomnia and depressive symptoms – a “no insomnia”/”low-stable” group, a “subclinical insomnia”/”moderate-stable” group, and a “clinical insomnia”/”high-improving” group.

3. The dual trajectory analysis revealed significant interrelationships between insomnia and depression, with the severity of symptoms co-occurring across the three trajectory groups.

4. Baseline factors including anxiety scores ≥24, insomnia scores ≥8, and depression scores ≥10 were common predictors of both adverse insomnia and depression trajectories, but social capital was not a significant predictor.

5. The findings highlight the importance of integrated screening and treatment approaches that simultaneously address comorbid insomnia and depression during the perinatal period.

6. Tailored interventions based on symptom trajectory profiles could help improve maternal mental health outcomes, and future research should further explore the temporal dynamics and underlying mechanisms linking these conditions.

Reference –

Xinlong Pan et al. (2025). Dual Trajectory Of Insomnia And Depressive Symptoms In Women From Early Pregnancy To 6 Months Postpartum: A Prospective Cohort Study. *BMC Pregnancy And Childbirth*, 25. https://doi.org/10.1186/s12884-025-07649-2.

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Ketamine could treat depression by interacting with the brain’s ‘opioid system: Study

Ketamine is a highly effective, fast-acting antidepressant that works even for patients who have not responded to other medications. However, the brain mechanisms important for these rapid treatment effects are yet to be determined.

Researchers at King’s College London, who are investigating why ketamine could be a good treatment for some people with depression, have discovered that the drug’s antidepressant effects involve the brain’s opioid system.

The study, led by King’s College London and published in Nature Medicine, included 26 individuals with clinically diagnosed depression who were given a low dose ketamine infusion across two sessions during neuroimaging.

Before receiving the ketamine infusion, in one session they were given naltrexone, which blocks the opioid receptors in the brain, and in the other they were given a placebo.

Participants were monitored during the infusion in a brain scanner using a method called magnetic resonance spectroscopy (MRS). MRS measured dynamic changes in a brain chemical called glutamate. Depressive symptoms were then assessed using the clinician-rated Montgomery-Åsberg Depression Rating Scale (MADRS) 24-hours after infusion, when ketamine’s antidepressive symptoms peak.

They found that blocking the opioid system reduced both the brain’s glutamatergic response and the antidepressant effects observed the following day, suggesting that the opioid system plays a key role in mediating the antidepressant response.

The study also identified a sex-related effect: the effect of naltrexone on glutamatergic activity appeared more pronounced in males with depression than in the females with depression.

These insights into how ketamine works for different people is essential to personalising treatments.

Dr Luke Jelen, lead author of the study and a Clinical Lecturer in Psychiatry at King’s College London, said: “Ketamine often makes the news for negative reasons. However, at a low dose, ketamine shows enormous potential to offer relief from the symptoms of depression.”

“Understanding whether the opioid system is involved ketamine’s antidepressant effects is a really important question, given how much we still don’t know about how ketamine works. “Our study shows that the opioid system is involved and offers insight into how it contributes to ketamine’s effects.”

The authors are keen to highlight that ketamine is not classified as an opioid and does not bind to opioid receptors with high affinity like morphine or heroin. Instead, the findings point to a dynamic interplay between the glutamatergic and opioid systems, which may work together to support ketamine’s rapid antidepressant effects.

Opiates can offer relief from the systems of depression however they are highly addictive. Understanding if and how the opioid system is involved in the effects of ketamine is important to understand why ketamine works and develop new, alternative treatments.

Low-dose ketamine is currently being used to treat depression in private clinics and a small number of NHS clinics. At higher doses it is also used in medicinal anaesthesia. However, it is also used recreationally and if misused can cause serious health problems including irreversible damage to the bladder and kidneys.

Professor Mitul Mehta, a professor of neuroimaging & psychopharmacology at King’s College London, said: “The brain’s different neurochemical systems work together to produce our experiences and behaviour so it is no surprise that the opiate system may have a role in ketamine’s antidepressant effect.”

“We need these kinds of studies to understand exactly what the important brain mechanisms are for antidepressant effects. Understanding more about how ketamine works can lead to treatment being personalised for different people, which is vital for creating safe and effective treatments.”

Reference:

Jelen, L.A., Lythgoe, D.J., Stone, J.M. et al. Effect of naltrexone pretreatment on ketamine-induced glutamatergic activity and symptoms of depression: a randomized crossover study. Nat Med (2025). https://doi.org/10.1038/s41591-025-03800-w

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International radiology consensus outlines best practices for post-COVID CT: Study

 Experts representing multiple societies and institutions across 14 countries have published guidance for computed tomography (CT) imaging in patients with residual lung abnormalities after COVID-19 illness. The consensus statement appears today in Radiology, a journal of the Radiological Society of North America (RSNA).

The statement’s authors seek to standardize the indications for when chest CT is appropriate for patients with post–COVID-19 condition, the methods for acquiring images and the terminology used for reporting residual lung abnormalities. The final consensus was reviewed by four expert pulmonologists to ensure alignment with clinical perspectives.

Using standardized and specific terminology when reporting these abnormalities helps to avoid confusion with interstitial lung diseases (ILDs), explained statement coauthor Anna Rita Larici, M.D., an associate professor of radiology at Catholic University of the Sacred Heart of Rome and chief of the Chest Imaging Unit at Advanced Radiology Center of Agostino Gemelli University Polyclinic Foundation in Rome, Italy. It also helps physicians make more informed decisions about patient management, and it captures more precise data for future research.

“These statements recommend employing terms from the Fleischner Society Glossary to describe CT findings consistently and precisely, avoiding the use of ‘interstitial lung abnormality (ILA),’ which refers to a different clinical context,” Dr. Larici said. “In addition, we have coined and recommended the term ‘post–COVID-19 residual lung abnormality’ to prevent any misleading term when describing CT lung abnormalities following COVID-19 pneumonia.”

The authors also outlined the conditions under which chest CT imaging is appropriate for this patient group. They recommend chest CT for patients whose respiratory symptoms continue or worsen three months after infection, with these symptoms lasting for at least two months and with no other explanation. A chest CT scan three to six months after discharge may also be considered for all patients hospitalized with moderate to severe COVID-19 due to the high rate of residual CT lung abnormalities observed in these patients.

The group suggests that follow-up be guided by radiological expertise in conjunction with clinical judgment, considering its frequency based on the extent of initial lung abnormalities, temporal changes and/or pulmonary physiology.

Radiologists should adhere to the “as low as reasonably achievable” (ALARA) principle for serial CT follow-up, using a low-dose protocol within a range of 1 to 3 millisieverts, the authors advised.

“Radiologists play a crucial role in adhering to ALARA principles by optimizing CT protocols—using appropriate low-dose techniques during follow-ups—while maintaining the image quality necessary for accurate assessment,” Dr. Larici said. “This is especially important when serial imaging of these patients is needed, so that we minimize radiation exposure without compromising diagnostic accuracy.”

COVID-19 can cause continuing or worsening symptoms after infection—described as post–COVID-19 condition or “long COVID”—and approximately 6% of individuals who have had COVID-19 are estimated to experience post–COVID-19 condition. Among patients hospitalized for acute COVID-19, on average, 50% show chest CT abnormalities, and 25% have restrictive pulmonary functional abnormalities at four months after infection. Radiologists face several unique challenges when caring for this patient population.

“These include differentiating between persistent residual COVID-19 lung abnormalities and evolving fibrotic changes, interpreting overlapping features such as ground-glass opacities versus fibrosis, and assessing the temporal evolution of these findings,” Dr. Larici explained. “Distinguishing post–COVID-19 residual lung abnormalities from ILA and ILDs is crucial, because they have very different clinical implications: post–COVID-19 changes typically stabilize over time, whereas ILA and ILDs can progress.”

It’s important to understand that post–COVID-19 lung abnormalities can persist for months and potentially impact respiratory health, she said.

“Follow-up imaging plays a key role in assessing these residual changes and guiding clinical care, but it should be performed judiciously. Adherence to established recommendations helps ensure that patients receive follow-up imaging and care only when clinically indicated,” Dr. Larici said.

Dr. Larici noted that being part of a global team of experts working together signifies a collective effort to establish evidence-based, harmonized best practices for caring for patients recovering from post–COVID-19 pneumonia.

“It reflects a commitment to advancing patient care worldwide through shared knowledge, research and consensus,” she said.

Reference:

Soon Ho Yoon, Best Practice: International Multisociety Consensus Statement for Post–COVID-19 Residual Abnormalities on Chest CT Scans, Radiology, https://doi.org/10.1148/radiol.243374

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Study reveals spinning could reduce NHS waiting lists for physiotherapy treatments in the UK

A new study by Bournemouth University (BU) and University Hospitals Dorset (UHD) has revealed the benefits of spinning for patients with hip osteoarthritis. The study is published in The Lancet Rheumatology.

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New research shows promise for targeted therapies for pediatric gliomas

A collaborative study between Dana-Farber Cancer Institute and the Broad Institute found that 8.9% of children with glioma, the most common form of pediatric brain tumor, have alterations in the fibroblast growth factor receptor (FGFR) family of proteins, and that these gliomas may be sensitive to existing U.S. Food and Drug Administration (FDA) approved inhibitors that broadly block FGFR.

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AI model uses glucose spikes to reveal hidden diabetes risk before symptoms appear

To diagnose either type 2 diabetes or pre-diabetes, clinicians typically rely on a lab value known as HbA1c. This test captures a person’s average blood glucose levels over the previous few months. But HbA1c cannot predict who is at highest risk of progressing from healthy to prediabetic, or from prediabetic to full-blown diabetes.

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Trump warns pharma companies to cut prices or be punished

US President Donald Trump told major pharmaceutical firms Thursday to lower prices or face punishment, as he moved to give Americans relief from medicine costs much higher than elsewhere in the world.

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