Functional ConstipationInsideNCT04282551
The Inside Study: Oligosaccharides Versus Placebo in Functional Constipation
A study testing dietary intervention with oligosaccharides in people with Functional Constipation, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Functional Constipation
- What is being tested?
- dietary intervention with oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jun 2020to Nov 2022
- 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 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Children who suffer from any other GI complaints than functional constipation, known structural GI abnormalities, or previous GI surgery
- Any condition that would make it unsafe for the child to participate.
- Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry
- Children who are allergic to cow's milk or fish
- Use of antibiotics or other medicines or food supplements, and breast milk-feeding, 4 weeks prior to the study, except for the allowed escape medication
- Children that participate in another clinical trial
Trial locations and contacts
1 site in 1 country.
Carrie A Wegh, MSc contact
Netherlands1 site, 1 recruiting
- Recruiting
Emma Children's Hospital, UMC Amsterdam
Amsterdam, North Holland, 1105AZ
Marc A. Benninga, Prof. MD, 003120-56680000, m.a.benninga@amsterdamumc.nl
About this study
Official title: The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation
In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.
Read the detailed description
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.
- Conditions
- Functional Constipation
- Being tested
- dietary intervention with oligosaccharides
- Keywords
- oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary intervention with oligosaccharidesOther
intervention with oligosaccharide 1 or 2, or placebo, given once a day
| Study group | Role | What they receive |
|---|---|---|
| oligosaccharide group 1 | Experimental | Not described Receives: Other: dietary intervention with oligosaccharides |
| oligosaccharide group 2 | Experimental | Not described Receives: Other: dietary intervention with oligosaccharides |
| placebo group | Placebo comparator | Not described Receives: Other: dietary intervention with oligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stool consistency
Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)
Measured: Stool consistency will be measured at different time points during a study period of 13 weeks.
Secondary outcomes (2)
Stool frequency in number of cases (%)
Stool frequency - number of times a child has stools a day as reported in a diary.
Measured: These outcome measures will be measured at different time point during a study period of 13 weeks.
Stool consistency in number of cases (%)
Stool consistency - % of stools in a certain stool scale score as measured via a 5 point stool scale
Measured: These outcome measures will be measured at different time point during a study period of 13 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start24 Jun 2020
- Primary completionNov 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study with three arms of 13 weeks in total per participant.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wageningen University and Research
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands, Sensus (Royal Cosun), the Netherlands.
- Responsible party
- Principal investigator, Clara Belzer, Wageningen University and Research
- Investigators
- Clara Belzer, PhD, Principal investigator, Wageningen University and ResearchMarc A Benninga, PhD, Principal investigator, Emma Children's Hospital, UMC Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282551
- Sponsor's protocol ID
- NL70126.081.19
- Acronym
- Inside
- Status last verified
- Oct 2021
- First submitted
- 6 Dec 2019
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wegh CAM, Schoterman MHC, Vaughan EE, van der Zalm SCC, Smidt H, Belzer C, A Benninga M. Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial. Trials. 2024 Apr 5;25(1):238. doi: 10.1186/s13063-024-08050-8.
PubMed 38576033
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oligosaccharides Versus a Placebo on Bowel Habits in Children With Functional Constipation
- ClinicalTrials.gov ID
- NCT04282551
- Acronym / sponsor ID
- Inside / NL70126.081.19
- Conditions
- Functional Constipation
- Keywords
- oligosaccharides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands, Sensus (Royal Cosun), the Netherlands.
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 24 Feb 2020 (actual)
- 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.
In the present randomised double blind controlled study, the investigators will study the effects of oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with functional constipation.
Detailed description
Functional constipation (FC) in children is a common gastrointestinal (GI) disorder with a worldwide prevalence ranging from 0.7% to 29.6%. Complaints include infrequent bowel movement, painful defecation due to hard and/or large stools, fecal incontinence, and abdominal pain. Although the condition is rarely life-threatening, it strongly impairs quality of life. Oligosaccharides have been shown to relieve constipation symptoms in young adults and elderly. However, sufficient evidence is lacking linking oligosaccharides intake to improve symptoms in children with FC. The investigators hypothesize that oligosaccharides might be able to relieve symptoms of constipation in young children as well, among which softening stools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel study with three arms of 13 weeks in total per participant.
| Arm | Type | Receives |
|---|---|---|
| oligosaccharide group 1 | Experimental | Other: dietary intervention with oligosaccharides |
| oligosaccharide group 2 | Experimental | Other: dietary intervention with oligosaccharides |
| placebo group | Placebo comparator | Other: dietary intervention with oligosaccharides |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Children who suffer from any other GI complaints than functional constipation, known structural GI abnormalities, or previous GI surgery
- Any condition that would make it unsafe for the child to participate.
- Children with clinically significant cardiac, vascular, liver, pulmonary, psychiatric disorders, severe renal insufficiency, human immunodeficiency virus, acquired immunodeficiency syndrome, hepatitis B or C or known abnormalities of haematology, urinalysis, or blood biochemistry
- Children who are allergic to cow's milk or fish
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 |
|---|---|---|
| dietary intervention with oligosaccharidesintervention with oligosaccharide 1 or 2, or placebo, given once a day | Other | oligosaccharide group 1, oligosaccharide group 2, placebo group |
Primary outcome
Stool consistency
Time frame: Stool consistency will be measured at different time points during a study period of 13 weeks.
Change in stool consistency measured by the a stool questionnaire; 5 points stool scale from 1 hard to 5 watery (modified Bristol Stool Form Scale)
2 secondary outcomes
Stool frequency in number of cases (%)
Time frame: These outcome measures will be measured at different time point during a study period of 13 weeks.
Stool consistency in number of cases (%)
Time frame: These outcome measures will be measured at different time point during a study period of 13 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 38576033Wegh CAM, Schoterman MHC, Vaughan EE, van der Zalm SCC, Smidt H, Belzer C, A Benninga M. Effect of prebiotic oligosaccharides on bowel habit and the gut microbiota in children with functional constipation (Inside study): study protocol for a randomised, placebo-controlled, multi-centre trial. Trials. 2024 Apr 5;25(1):238. doi: 10.1186/s13063-024-08050-8.
- Individual participant dataSharing planned: No
Related trials for Functional Constipation
Active, not recruitingPhase 2
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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Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation
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The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.
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Fiber Nutritional Supplement for Management of Constipation During Pregnancy
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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.
Carrie A Wegh, MSc contact
Clara Belzer, PhD principal investigator
Wageningen University and Research
Marc A Benninga, PhD principal investigator
Emma Children's Hospital, UMC Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention with oligosaccharides in people with Functional Constipation, run by Wageningen University and 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 0 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Oct 2021. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Clara Belzer, PhD (0031317-483742, clara.belzer@wur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stool consistency (time frame: Stool consistency will be measured at different time points during a study period of 13 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04282551, which also lists 1 linked publication.
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 12 Oct 2021; AzTrials last refreshed its copy on 2 Nov 2026.