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

NCT04543474 | Completed

• 1 other identifier: 130225
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from gastrointestinal symptoms in Irritable Bowel Syndrome (IBS symptom severity score) from Baseline to "post intervention diet".

  The symptom severity score (IBS-SSS) is a validated score to evaluate the severity of an IBS. The five subscores for abdominal pain (severity and frequency), abdominal distension, satisfaction with stool habits and interference of IBS with daily life were each rated on a VAS (visual analogue scale) 0-100 mm scale and added up to a maximal sum of 500. A total score of 75 - 175 was regarded as mild, 175 - 300 as moderate and \> 300 as severe IBS.

  The IBS SSS was assessed at the end of the run in period and at the end of the intervention diets (low lactose and low FODMAP diet) at day 14, 35 and 77.

Secondary Outcomes (9)

• IBS symptom severity subscore "abdominal pain severity"

  IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.

• IBS- symptom severity subscore "abdominal pain frequency"

  IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.

• IBS- symptom severity subscore "abdominal distension"

  IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.

• IBS symptom severity subscore "satisfaction with stool habits"

  IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.

• IBS symptom severity subscore "interference of IBS with daily life"

  IBS subscores were assesses at the end of each trial phase (run-in, first intervention diet, wash-out, second intervention diet) at day 14, 35, 56 and 77.

Study Arms (2)

Group 1

ACTIVE COMPARATOR

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

Other: Low Lactose Diet; Other: Low FODMAP Diet

Group 2

ACTIVE COMPARATOR

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.

Other: Low Lactose Diet; Other: Low FODMAP Diet

Interventions

Low Lactose Diet 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 1; Group 2

Low FODMAP Diet 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 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cantonal Hospital of St. Gallen: lead

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: September 10, 2020
• Study Start: March 11, 2015
• Primary Completion: September 19, 2017
• Study Completion: December 19, 2017
• Last Updated: September 10, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share