Healthy With Hard and/or Lumpy StoolsNCT04295213
The Inside Study II: Oligosaccharides Versus Placebo and Hard Stools
A study testing oligosaccharides in people with Healthy With Hard and/or Lumpy Stools, run by Wageningen University and Research at 1 site in Netherlands.
Trial summary
In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools. Read more about this study
- Who is it for?
- Ages 1 year to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy With Hard and/or Lumpy Stools
- What is being tested?
- oligosaccharides
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Apr 2021to Sep 2023
- 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Written informed consent
- aged 1-4 years
- Hard and/or firm stools as scored by a stool questionnaire
Who cannot join
- Children that meet the Rome IV criteria for functional constipation
- Children who suffer from any other GI complaints, 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, as checked by the inclusion questionnaire.
- Children who are allergic to cow's milk or fish
- Use of antibiotics or other medicines or food supplements, and breast milkfeeding, which can influence defecation and gut microbiota 4 weeks prior to the study
- Children that participate in another clinical trial
Trial locations and contacts
1 site in 1 country.
Carrie Wegh, MSc contact
Netherlands1 site, 1 recruiting
- Recruiting
Wageningen University and Research
Wageningen, Gelderland, 6708 WE
Carrie A.M. Wegh, MSc, 00316-39267118, carrie.wegh@wur.nl
Clara Belzer, PhD, clara.belzer@wur.nl
About this study
Official title: The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools
In the present randomised double blind controlled study, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools.
Read the detailed description
Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.
- Conditions
- Healthy With Hard and/or Lumpy Stools
- Being tested
- oligosaccharides
- Keywords
- oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oligosaccharidesOther
1 dose a day of oligosaccharides or placebo
| Study group | Role | What they receive |
|---|---|---|
| oligosaccharide group | Experimental | intervention with oligosaccharides, total duration of study is 13 weeks Receives: Other: oligosaccharides |
| placebo group | Placebo comparator | Placebo comparator, total duration of study is 13 weeks Receives: Other: 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.by a stool questionnaire
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 posted4 Mar 2020
- Study start28 Apr 2021
- Primary completionJul 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy With Hard and/or Lumpy StoolsStudies 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 two arms of 13 weeks in total per participant
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 196 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
- Responsible party
- Principal investigator, Clara Belzer, Wageningen University and Research
- Investigators
- Clara Belzer, PhD, Principal investigator, Wageningen University and ResearchMarc Benninga, PhD, Principal investigator, Emma Children's Hospital, UMC Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295213
- Sponsor's protocol ID
- NL70820.081.19
- Status last verified
- Jul 2022
- First submitted
- 2 Mar 2020
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Oligosaccharides Versus a Placebo on Defecation Parameters in Healthy Children With Hard or Lumpy Stools
- ClinicalTrials.gov ID
- NCT04295213
- Acronym / sponsor ID
- NL70820.081.19
- Conditions
- Healthy With Hard and/or Lumpy Stools
- Keywords
- oligosaccharides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Wageningen University and ResearchUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), FrieslandCampina, Amersfoort, The Netherlands
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 4 Mar 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, we will study the effects of a oligosaccharides vs a placebo on the change in stool consistency and stool frequency in children with hard or lumpy stools.
Detailed description
Firm, hard or lumpy stools can be problematic for young children and might come as a precursor of functional constipation in childhood. The cause of harder stools in childhood is incompletely understood. But it is likely that harder stools in childhood are linked to among others withholding behaviour of stools and a low fibre intake. As hard stools may precede functional constipation, the aim of the study is to investigate the effect of a prebiotic fiber versus a placebo on defecation parameters in healthy children with hard or lumpy stools. We hypothesize that consumption of a prebiotic fiber results in softer stools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel study with two arms of 13 weeks in total per participant
| Arm | Type | Receives |
|---|---|---|
| oligosaccharide group | Experimental | Other: oligosaccharidesintervention with oligosaccharides, total duration of study is 13 weeks |
| placebo group | Placebo comparator | Other: oligosaccharidesPlacebo comparator, total duration of study is 13 weeks |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Written informed consent
- aged 1-4 years
- Hard and/or firm stools as scored by a stool questionnaire
Key exclusion criteria (7 listed)
- Children that meet the Rome IV criteria for functional constipation
- Children who suffer from any other GI complaints, 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, as checked by the inclusion questionnaire.
- 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 |
|---|---|---|
| oligosaccharides1 dose a day of oligosaccharides or placebo | Other | oligosaccharide group, 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 13 Jul 2022.
- Individual participant dataSharing planned: No
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 Wegh, MSc contact
Clara Belzer, PhD principal investigator
Wageningen University and Research
Marc 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 oligosaccharides in people with Healthy With Hard and/or Lumpy Stools, 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 3 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 13 Jul 2022. 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 (0031317-483 742, 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?
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 13 Jul 2022.