NCT04790422

Nutrition to Relieve IBS Symptoms by Targeting the Microbiota

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Wageningen University and Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Rationale: Irritable Bowel Syndrome (IBS) is functional gastrointestinal disorder that affects a large number of people. To date, no adequate treatment is available. This is partially due to the heterogeneity of the patients and the complicated pathology in which not all mechanisms are understood. Based on results of in vitro screening within the IBSQUtrition project, we selected promising dietary supplements for validation of their potential beneficial effects on the microbiota of IBS patients. Objective: The primary objective is to determine the bifidogenic effects of a 4-week intervention with one of four dietary supplements (Chondroitin sulfate, NOVELOSE® 3490, and Pea Fiber, and Lactium®) in IBS patients. The secondary objective is to determine the effects of the same intervention on fecal microbiota composition and SCFA concentration, IBS-related complaints, Quality of Life, and stool frequency and consistency in IBS patients. Study design: a double-blind, randomized, placebo-controlled trial with five parallel arms. Study population: 70 adult (18-65 yrs) IBS patients Intervention: 4-week intervention period with five parallel arms: 1) Chondroitin sulfate, 2) NOVELOSE® 3490, 3) Pea Fiber, 4) Lactium®, and 5) Placebo supplement (Maltodextrin control), during which the study participants consume the respective supplement twice per day. Main study parameters/endpoints: The main study parameter is the (relative) abundance of fecal Bifidobacterium. The secondary study parameters are fecal microbiota composition and Short-Chain Fatty Acids (SCFAs) concentration, stool frequency and consistency, IBS-related complaints, and Quality of Life (QoL). Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Study participants have to invest about 7.4 hours of their time in this study mainly to complete several questionnaires (short daily questionnaire, longer questionnaires at two occasions), which is conveniently all possible from home. On two occasions they have to collect stool (transported via courier to the research facility). They have to comply to consume a commercially available supplement twice daily for four weeks. There are limited risks for the study participants.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary fiber supplement	Dietary fiber
DIETARY_SUPPLEMENT	Caseine protein hydrolisate	Dietary supplement
DIETARY_SUPPLEMENT	Maltrodextrine	Placebo comparator

Timeline

• Start date: 2021-05-11
• Primary completion: 2021-07-16
• Completion: 2021-07-16
• First posted: 2021-03-10
• Last updated: 2021-07-30

Locations

1 site across 1 country: Netherlands