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New treatment option for Bowel Function Dissatisfaction
Official title Impact of a Dried Vegetable on Bowel Function and Gut Microbiota
ClinicalTrials.gov ID: NCT05473793
What this study is testing
- What it's testing
- A randomized, placebo-controlled, parallel, double-blind trial with three intervention arms and a period of four intervention-weeks that assesses the intake of different dosages of a complex fiber product on bowel function via microbiota changes in subjects that are unsatisfied with their current bowel function.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 20 - 80 years old
- Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6
- Four or less bowel movements per week (low stool frequency) and/or
- Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)
- Able to read and understand Dutch or English
You likely can't join if
- Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and people with medically...
- Less than one bowel movement per week during the screening
- Medical drug use:
- Antibiotic use within 3 months of the study screenings day
- Chronic use of antacids and PPI's
- Use of laxatives during the screening
See the full eligibility criteria
- 20 - 80 years old
- Unsatisfied with bowel functions (self-reported), rated on a visual analogue scale (VAS, 0-10) as less than 6
- Four or less bowel movements per week (low stool frequency) and/or
- Hard, lumpy or solid stools (Bristol stool form 1-4) during 90% of bowel movements (hard to solid consistency)
- Able to read and understand Dutch or English
- Having a history of medical or surgical events that may significantly affect the study outcome: e.g., IBS or IBD patients and people with medically diagnosed constipation (i.e., constipation related to anatomic...
- Less than one bowel movement per week during the screening
- Medical drug use:
- Antibiotic use within 3 months of the study screenings day
- Chronic use of antacids and PPI's
- Use of laxatives during the screening
- Chronic use of blood glucose lowering medication
- Consumption of supplements containing fibres (other than laxatives), pro-/ post-/ synbiotics 1 month before the screening
- Not willing to provide faecal samples
- Unable to comply with proper study procedures
- For women of childbearing age: current or planned pregnancy, lactation
- Known allergic reactions to plants from the Asteraceae (Compositae) family (e.g., lettuce, daisies, sunflowers, artichokes, sage, tarragon, chamomile, chicory etc.)
- Reported unexplained weight loss or weight gain of greater than 5 kg in the month prior to pre-study screening
- Reported slimming or medically prescribed diet
- Reported macrobiotic lifestyle
- Personnel the Division of Human Nutrition \& Health or the Laboratory of Microbiology
- Current participation in other medical scientific research
- Not having a general practitioner
- Not willing to be informed about accidental discoveries in relation to the people health
The study team makes the final eligibility decision.
Where it's taking place
- Wageningen, Gelderland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wageningen, Gelderland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.