Treatment Efficacy of Low FODMAP Versus Low Lactose Diet in IBS Patients

Status Completed

Clinical Trial Summary

A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS) patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over trial with IBS patients.

Clinical Trial Description

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder. It affects 10 - 20% of the adult population. Pharmaceutical therapy as bulking agents, anticholinergics, antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists recommend therefore dietary management. Most patients note that various foods elicit abdominal symptoms and therefore restrict their diet .

The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet has currently the greatest evidence for efficacy in IBS. The rationale behind the LFD is the exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load, drag fluid into the small intestine and would be fermented by the colonic microbiome, both leading to abdominal distention and increased luminal influx. FODMAPs do not cause symptoms in healthy adults as they neither show these abnormalities in gut physiology nor suffer from visceral hypersensitivity .

It is not known however whether change in symptoms is induced by a reduction in all FODMAPs or simply a single component as for example lactose. If there is a lactase deficiency, as it is the case in 2-20% of Central- / Northern Europeans, lactose cannot be hydrolysed and causes the above mentioned symptoms. Many IBS patients avoid lactose, even though only few have a lactase deficiency. Lactose intolerance but not lactase deficiency is more frequent in patients with IBS. The investigator wanted to examine if the demanding LFD is more effective than elimination of lactose alone.

Our study, comparing in detail the effects of low FODMAP versus low lactose diet in IBS patients is a novelty, analysing a clinically highly relevant topic. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04543474
Study type	Interventional
Source	Cantonal Hospital of St. Gallen
Contact
Status	Completed
Phase	N/A
Start date	March 11, 2015
Completion date	December 19, 2017

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05118243` - Innovative Tools to Produce Legume-based Foods for Increased Consumer Acceptance	N/A
Completed	`NCT04422327` - The Impact of a Combination of Bifidobacterium Longum 35624® and 1714™ Strains in Adults With Irritable Bowel Syndrome	Phase 1/Phase 2
Recruiting	`NCT05178017` - Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)	N/A
Completed	`NCT05197413` - Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms	N/A
Completed	`NCT04905524` - Activity Changes in Irritable Bowel Syndrome (IBS), Anxiety, and Depression Following the Use of Viome Precision Nutrition Program (VPNP)	N/A
Recruiting	`NCT06297785` - Online, Gut-directed Hypnotherapy for Patients With Irritable Bowel Syndrome (IBS)	N/A
Recruiting	`NCT05874830` - The Optimal Route of Fecal Microbiota Transplantation for Irritable Bowel Syndrome	N/A
Active, not recruiting	`NCT04723056` - Zemedy Application for Irritable Bowel Syndrome	N/A
Completed	`NCT05565612` - Clinical Trial to Evaluate the Effect of a Probiotic Mixture on Signs and Symptoms of Irritable Bowel Syndrome	N/A
Recruiting	`NCT03131414` - The IMAGINE-SPOR CIHR Chronic Disease Network
Completed	`NCT03333291` - Fecal Transplantation in Patients With IBS	N/A
Completed	`NCT03449628` - L. Casei DG® in Patients With Irritable Bowel Syndrome.	N/A
Recruiting	`NCT06215222` - Capsule Microbiota Sampling in IBS/Functional Gastrointestinal Disease
Completed	`NCT05016596` - Postprandial Lipids in IBS and Nutritional Treatment	N/A
Recruiting	`NCT04760353` - The Effect of a Probiotic Mixture in Obese Patients With Irritable Bowel Syndrome	N/A
Completed	`NCT06426745` - Split-dose Versus Single-dose Bowel Preparation for Colonoscopy	N/A
Recruiting	`NCT04217733` - Ethosuximide and Pentoxifylline in the Treatment of Abdominal Pain Related to Irritable Bowel Syndrome	Phase 3
Completed	`NCT03178877` - The Prevalence of Irritable Bowel Syndrome Using Rome IV Criteria in Medical Student and The Related Factors	N/A
Recruiting	`NCT05990764` - Effects of a Combination of Polyphenol-rich Extracts, Prebiotics, and Hydrolyzed Fiber on the Quality of Life of Patients With Irritable Bowel Syndrome (IBS)	N/A
Completed	`NCT03948854` - Implementing a Low FODMAP Diet in Irritable Bowel Syndrome Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.