Constipation Stoppage
Conditions
Interventions
The patients need to take twice a day one sachet during four weeks. The powder
in the sachet needs to be mixed with 200ml of water.
• Study group 1: low high quantity fiber containing product (6g/sac
Sponsors
Nestec
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Adult men or women (female subjects of child-bearing potential must be willing to use a reliable method of contraception throughout the study period) • Age 18 - 75 • BMI: 18.5 - 29.9 kg/m2 • Symptoms of constipation for a minimum of 3 months • Recruitment based on simplified core ROME III diagnostic criteria for functional constipation (based on specific screening questions): o average Bristol stool type of 1 - 3 AND frequency of 1 - 3 spontaneous bowel movements (SBMs) per week o plus at least ONE of the following at screening: * straining on at least 25% of defaecations * sensation of incomplete evacuation on at least 25% of defaecations * sensation of anorectal obstruction / blockage on at least 25% of defaecations * use of manual manoeuvres on at least 25% of defaecations. • Cleveland Clinic constipation score (CCCS) of 8-20 • Low-moderate fibre intake (
Exclusion criteria
Exclusion criteria: • Subjects who report lactose intolerance and/or are allergic to soy or cow milk protein • Pregnant or breast-feeding women • Ongoing other diagnosed gastrointestinal disease or complication (Crohn's disease, Coeliac disease, chronic diarrhoea) • Any clinical relevant abnormalities in the screening visit medical examination or alarm features such as sudden unintentional weight loss, rectal bleeding, recent change in bowel habit (2 weeks inability to work in the 3 months before the study start • Subjects with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect gut motility or limit normal functions (e.g. reduced mobility or increased fragility) • Ongoing alcohol, drug, or medication abuse (anamnesis only) • Self-reported symptoms of pelvic organ prolapse • Moderate or severe active local anorectal problems such as recurrent anal fissures, bleeding, large prolapsing haemorrhoids, etc • Regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit and no more than 6 standard doses in the past 1 month prior to the screening visit • Participation in another study with any investigational product within 3 months of screening • Investigator believes that the participant is physically or mentally unfit to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate change in whole gut transit time at the mid-consumption period timepoint (+2 weeks) in constipated patients consuming the study food product containing fiber in high quantity (Group 1), compared to those consuming placebo (Group 3). | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assess change in gastrointestinal symptoms during the consumption period of the study food product • Assess tolerance to the study food product • Evaluate physiological and symptomatic endpoint(s) that best correlate with gut transit time • Evaluate changes in regional (right colon, left colon, and rectosigmoid) colonic transit times at the mid-consumption period timepoint (+2 weeks) • Evaluate change in whole gut transit time at the mid-consumption period timepoint (+2 weeks) in constipated patients consuming the study food product containing fiber in low quantity (Group 2), compared to those consuming placebo (Group 3) | — |
Countries
Netherlands
Outcome results
None listed