Stichting Wageningen Research
Wageningen, Gelderland, 6708 WG, Netherlands
NCT Number: NCT04790422
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.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Wageningen, Gelderland, 6708 WG, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary fiber
Dietary supplement
Placebo comparator
Time frame: Change after the intervention of 4 weeks
Measured in fecal samples using 16S rRNA gene-based approaches
Time frame: Change after the intervention of 4 weeks
Measured in fecal samples using 16S rRNA gene-based approaches
Time frame: Change after the intervention of 4 weeks
Measured in the fecal samples using HPLC
Time frame: daily during 4 weeks
Questions regarding how often participants defecate
Time frame: daily during 4 weeks
Using the validated Bristol stool chart
Time frame: daily during 4 weeks
Measured with a visual analog scale
Time frame: 4 weeks
measured using the validated IBS-SSS questionnaire
Time frame: 4 weeks
measured using the validated IBS-QoL questionnaire
Time frame: 4 weeks
measuring using the validated hospital anxiety and despression score (HADS) questionnaire
Time frame: 4 weeks
Measured via a validated food frequency questionnaire (FFQ)
Wageningen University and Research
Other
Acronym: NUTRIMI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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