RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Low FODMAP diet for Functional Gastrointestinal Disorders (FGIDs)

Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is : How does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ?

Official registry: https://clinicaltrials.gov/study/NCT07000227 · Universiti Kebangsaan Malaysia Medical Centre · enrollment listed as 60

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Low FODMAP diet, Gentle FODMAP diet, or Traditional Dietary Advice. The registry lists allocation as randomized. Brief Summary : The goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients.

They plan to enroll about 60 people at Kuala Lumpur. Taking part typically means following a program (exercise, therapy, diet, or an app) plus check-ins.

Official title (unrewritten)

Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial

Interventions: Low FODMAP diet, Gentle FODMAP diet, Traditional Dietary Advice

Primary outcome (registry wording): Effect of FODMAP restrictions on Gut Microbiota Abundance and Diversity

Who it is for (from inclusion criteria)

Ages 18 Years to any
Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists
Meet the ROME III- Asian criteria for FGID
Able to communicate in Malay or English language

Who the registry excludes

Pregnant or lactating women
History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis
Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma
Habitual use of opiate analgesics likely to alter bowel function e.g. morphine
Use of antibiotics in the preceding two weeks and/or in the past one month
Consumption of probiotics, prebiotics or fibre supplements in the past one month
Enteral feeding or texture modified diet patients

Public study contact (from the registry)

Shanthi Krishnasamy, Dr

+60182017116

shanthikrishnasamy@ukm.edu.my

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak — Kuala Lumpur, Kuala Lumpur, Malaysia (recruiting)

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FAQ about this NCT record

Is NCT07000227 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07000227?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07000227?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary