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

NCT ID: NCT04543474

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-11
• Study Completion Date: 2017-12-19

Brief 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.

Detailed 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.

Conditions

IBS - Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Patients starting with a low lactose diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low FODMAP diet for 3 weeks

Group Type: ACTIVE_COMPARATOR

Low Lactose Diet

Intervention Type: OTHER

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Low FODMAP Diet

Intervention Type: OTHER

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Group 2

Patients starting with a low FODMAP diet for 3 weeks, followed by a wash out phase of 3 week, before crossing over to the low lactose diet for 3 weeks.

Group Type: ACTIVE_COMPARATOR

Low Lactose Diet

Intervention Type: OTHER

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Low FODMAP Diet

Intervention Type: OTHER

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Interventions

Low Lactose Diet

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Intervention Type: OTHER

Low FODMAP Diet

First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• functional bowel symptoms as defined by the Rome IV criteria
• subjective lactose intolerance

Exclusion Criteria

• pharmacologic agents to alter symptoms (laxatives, antidiarrheal agents)
• smoking
• antibiotic therapy within the last 4 weeks
• gastrointestinal diseases (Celiac disease was excluded by negative serologic testing while on a gluten containing diet
• any type of food allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Claudia Krieger-Grübel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

130225

Identifier Type: -

Identifier Source: org_study_id