Functional ConstipationTOMCATNCT02140749
Trial on Short-chain Fructooligosaccharides, Microbiota, and Constipation in Adults
A study testing sc-FOS 2g/day, sc-FOS 4g/day and sc-FOS 8g/day in people with Functional Constipation, run by NIZO Food Research at 1 site in Netherlands.
Trial summary
Rationale: The dietary short-chain fructooligosaccharides 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- sc-FOS 2g/day, sc-FOS 4g/day and sc-FOS 8g/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 yr
- Agree to study design (signed informed consent)
- At least two of the following symptoms ≥25% of the time with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to inclusion (ROME III criteria for functional constipation):
- straining, lumpy or hard stool
- sensation of incomplete evacuation
- sensation of anorectal obstruction ⁄ blockage
Show all 12Show fewer
- use of manual manoeuvres
- <3 bowel movements per week
- Availability of internet connection
- BMI 20-30
- Male or female
- Willingness to abstain from functional ingredients and such as probiotics, prebiotics and foods containing high amounts of fermentable fibers and laxatives starting 1 month prior to start of the study as well as during the washout period.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Short-chain Fructooligosaccharides on Stool Frequency in Constipated Subjects
Rationale: The dietary short-chain fructooligosaccharides 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.
Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.
Read more
Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4 weeks.
Study population: Human subjects with functional constipation according to ROMEIII criteria (total n=120; male and female; 18-75 yr).
Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral chews.
Main study parameters: The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. Secondary outcomes 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).
- Conditions
- Functional Constipation
- Being tested
- sc-FOS 2g/day, sc-FOS 4g/day, sc-FOS 8g/day, Placebo
- Keywords
- Bifidobacteria, Bristol Stool Scale, Constipation, Diet, Fructooligosacchardes, Microbiota, Oligofructose
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sc-FOS 2g/dayDietary supplement
Also called FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Chewing tablets containing Short-chain fructooligosaccharides 2g/day
sc-FOS 4g/dayDietary supplement
Also called FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Chewing tablets containing short-chain Fructooligosaccharides 4g/day
sc-FOS 8g/dayDietary supplement
Also called FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharide
Chewing tablets containing short-chain Fructooligosaccharides 8g/day
PlaceboDietary supplement
Chewing tablets without short-chain Fructooligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| sc-FOS 2g/day | Experimental | Placebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks) Receives: Dietary Supplement: sc-FOS 2g/day; Dietary Supplement: Placebo |
| sc-FOS 4g/day | Experimental | Placebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks) Receives: Dietary Supplement: sc-FOS 4g/day; Dietary Supplement: Placebo |
| sc-FOS 8g/day | Experimental | Placebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks) Receives: Dietary Supplement: sc-FOS 8g/day; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool frequency (Number of complete bowel movements per day)
Measured: Change over week 4 and week 12
Secondary outcomes (3)
Stool consistency (Bristol Stool Scale)
Measured: Change over week 4 and week 12
Severity of symptoms (Constipation Scoring System; CSS)
Measured: Change over week 4 and week 12
Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)
Measured: Change over week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIZO Food Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ingredion Incorporated
- Responsible party
- Sponsor
- Investigators
- Sandra ten Bruggencate, PhD, Principal investigator, NIZO Food Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02140749
- Sponsor's protocol ID
- NL46640.081.14
- Acronym
- TOMCAT
- Status last verified
- Dec 2015
- First submitted
- 24 Apr 2014
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled Double-blind Cross-over Study to Evaluate the Effects of Short-chain Fructooligosaccharides on Stool Frequency in Constipated Subjects
- ClinicalTrials.gov ID
- NCT02140749
- Acronym / sponsor ID
- TOMCAT / NL46640.081.14
- Conditions
- Functional Constipation
- Keywords
- Bifidobacteria, Bristol Stool Scale, Constipation, Diet, Fructooligosacchardes, Microbiota, Oligofructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- NIZO Food ResearchUniversity, hospital or other
- Collaborators
- Ingredion Incorporated
- Study start
- Apr 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale: The dietary short-chain fructooligosaccharides 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.
Objective: Study the effect of short-chain fructooligosaccharides on functional constipation.
Study design: A 16-week, randomized, placebo-controlled, double-blind cross-over trial with intervention periods of 4 weeks with a run-in period of 4 weeks and a wash-out period of 4 weeks.
Study population: Human subjects with functional constipation according to ROMEIII criteria (total n=120; male and female; 18-75 yr).
Intervention: Placebo and one out of 3 dosages of short-chain fructo-oligosaccharides, (Degree of Polymerisation of 3-5; 2, 4 and 8 g/day) for 4 weeks. scFOS will be given as oral chews.
Main study parameters: The primary parameter is the number of complete bowel movements per day in subjects with functional constipation according to Rome III criteria. Secondary outcomes 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sc-FOS 2g/day | Experimental | Dietary Supplement: sc-FOS 2g/day, Dietary Supplement: PlaceboPlacebo (4 weeks) Short-chain fructooligosaccharide 2 g/day (4 weeks) |
| sc-FOS 4g/day | Experimental | Dietary Supplement: sc-FOS 4g/day, Dietary Supplement: PlaceboPlacebo (4 weeks) Short-chain fructooligosaccharide 4 g/day (4 weeks) |
| sc-FOS 8g/day | Experimental | Dietary Supplement: sc-FOS 8g/day, Dietary Supplement: PlaceboPlacebo (4 weeks) Short-chain fructooligosaccharide 8 g/day (4 weeks) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-75 yr
- Agree to study design (signed informed consent)
- At least two of the following symptoms ≥25% of the time with criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to inclusion (ROME III criteria for functional constipation):
- Availability of internet connection
- BMI 20-30
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sc-FOS 2g/dayAlso: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharideChewing tablets containing Short-chain fructooligosaccharides 2g/day | Dietary supplement | sc-FOS 2g/day |
| sc-FOS 4g/dayAlso: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharideChewing tablets containing short-chain Fructooligosaccharides 4g/day | Dietary supplement | sc-FOS 4g/day |
| sc-FOS 8g/dayAlso: FOS, Oligofructose, scFOS, Short-chain fructo-oligosaccharideChewing tablets containing short-chain Fructooligosaccharides 8g/day | Dietary supplement | sc-FOS 8g/day |
| PlaceboChewing tablets without short-chain Fructooligosaccharides | Dietary supplement | sc-FOS 2g/day, sc-FOS 4g/day, sc-FOS 8g/day |
Primary outcome
Stool frequency (Number of complete bowel movements per day)
Time frame: Change over week 4 and week 12
3 secondary outcomes
Stool consistency (Bristol Stool Scale)
Time frame: Change over week 4 and week 12
Severity of symptoms (Constipation Scoring System; CSS)
Time frame: Change over week 4 and week 12
Quality of Life (Patient Assessment of Constipation Quality of Life; PAC-QoL)
Time frame: Change over week 4 and week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Related InfoLink provided by the sponsor.
Related trials for Functional Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
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Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra ten Bruggencate, PhD principal investigator
NIZO Food Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sc-FOS 2g/day, sc-FOS 4g/day and sc-FOS 8g/day in people with Functional Constipation, run by NIZO Food Research at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool frequency (Number of complete bowel movements per day) (time frame: Change over week 4 and week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.