To study the effect of fructo-oligosaccharides on functional constipation.
ID
Source
Brief title
Condition
- Gastrointestinal motility and defaecation conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary parameter is the number of complete bowel movements per day in
subjects with functional constipation according to Rome III criteria.
Secondary outcome
Secondary outcome parameters are Stool consistency (Bristol Stool Scale), Stool
frequency, Severity of symptoms (Constipation Scoring System; CSS) and Quality
of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL).
Other study parameters:
Microbiota profile, fecal Bifidobacteria, Lactobacilli, Clostridia, E. coli and
total bacterial count. Blood samples will be taken at baseline and end of
treatment and stored for later analysis.
Background summary
The prevalence of functional constipation in Europe is estimated to be around
17%, making it a common disorder. The dietary non-digestible carbohydrates
fructo-oligosaccharides have been shown to increase fecal bacterial mass and
fermentation metabolites which might stimulate gut motility. Therefore, these
dietary non-digestible carbohydrates might relieve functional constipation.
Study objective
To study the effect of fructo-oligosaccharides on functional constipation.
Study design
A 16-week, randomized, placebo-controlled, double-blind cross-over trial with a
run-in period of 4 weeks, and two intervention periods of 4 weeks separated by
a wash-out period of 4 weeks.
During the study, participants need to stop the use of laxatives and pre- or
probiotic supplements.
Subjects will be stratified according to age, gender and number of bowel
movements (both determined at screening). All participants will have one
intervention period with one of the three treatment dosages, and one period
with placebo. The participants will be randomly allocated to these groups.
Intervention
Placebo and one out of 3 dosages of short-chain fructo-oligosaccharide,
NutraFlora® scFOS, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4
weeks. NutraFlora® scFOS will be given as oral chews.
Study burden and risks
Subjects will daily consume one out of 3 dosages of short-chain
fructo-oligosaccharide, NutraFlora® scFOS, (DP 3-5; 2, 4 and 8 g/day) and
placebo for 4 weeks. Supplementation of FOS can cause flatulence, belching,
abdominal pain, and bloating at the onset of treatment. Symptoms are generally
very mild at the lower doses tested in the present trial (less than 10 g daily).
Subjects will be instructed to maintain their usual pattern of physical
activity during the intervention periods. The subjects can maintain their
habitual diet, with the exception of functional ingredients like pre- and
probiotics and food products high in dietary fermentable fibers. Moreover, use
of other laxatives is prohibited during the intervention periods. The subjects
are asked to fill in an online diary during the intervention periods to record
compliance to dietary guidelines and test product intake. Additionally, in week
1 , 4, 9 and 12 the subjects are asked to record the Bristol Stool Form Scale,
Stool frequency and the CSS and PAC-QoL questionnaires. Additionally, subjects
are asked to collect a faecal sample in week 1, 4, 9 and 12. Blood samples will
be collected in week 1, 4, 9 and 12.
The subjects will not benefit directly from participation to the study. The
risks associated with participation in this study are considered negligible.
The main burden of this study consists of the intestinal complaints subjects
will experience when not using laxatives and/or dietary fibres in the run-in
period and placebo intervention periods. In addition, the burden will include
the time involved in filling in the questionnaires, the blood collection (4
times) and the fecal sample collection (4 times).
Finderne Ave 10
Bridgewater NJ 08807
US
Finderne Ave 10
Bridgewater NJ 08807
US
Listed location countries
Age
Inclusion criteria
Age 18-75 yr
• Agree to study design (signed informed consent)
• At least two of the following symptoms >=25% of the defecations (ROME III) with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to study start:
o straining, lumpy or hard stool
o sensation of incomplete evacuation
o sensation of anorectal obstruction * blockage
o use of manual manoeuvres
o <3 bowel movements per week
• Availability of internet connection
• BMI 20-30
• Male and/or female
• Willingness to abstain from functional ingredients and such as probiotics, prebiotics, foods containing high amounts of fermentable fibers, and laxatives during the study.
Exclusion criteria
• Currently participating in another clinical trial
• Drug usage
• Excessive alcohol usage (>4 consumptions/day or >20 consumptions/week)
• Pregnancy or lactating
• Underlying disease of the GI-tract or previous laparotomy, except cholecystectomy and appendectomy.
• Use of antibiotics within 1 month prior to inclusion
• Vegetarians
• Weight loss >5 kg within 1 month prior to inclusion
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46640.081.14 |