Healthy InfantsPhase 2ColoRNCT01507935
Colonisation Resistance Study
A Phase 2 study testing Regular non-hydrolysed cow's milk in people with Healthy Infants, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Thailand.
Trial summary
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins. Read more about this study
- Who is it for?
- Ages 8 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Regular non-hydrolysed cow's milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesThailand
- Study dates
- Jan 2012to Nov 2012
- Phase
- Phase 2
- 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 8 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
- Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
- Parents' or guardian's written informed consent
Who cannot join
- Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
- Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
- Significant congenital abnormality that could affect the study results
- Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
- Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements
- Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- Gastroenteritis in the last two weeks before inclusion
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
About this study
Official title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
- Conditions
- Healthy Infants
- Being tested
- Regular non-hydrolysed cow's milk
- Keywords
- Healthy infants, Infant formula, Prebiotics oligosaccharides, Colonisation Resistance, Gut Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular non-hydrolysed cow's milkOther
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
Regular non-hydrolysed cow's milkOther
Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
Regular non-hydrolysed cow's milkOther
Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group I | Active comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I Receives: Other: Regular non-hydrolysed cow's milk |
| Intervention Group II | Active comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II Receives: Other: Regular non-hydrolysed cow's milk |
| Control Group | Placebo comparator | Healthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides Receives: Other: Regular non-hydrolysed cow's milk |
| Reference group | No intervention | Exclusively breast-fed infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiota composition and its metabolic activity
- Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut
- Metabolic activity of the gut microbiota: pH, SCFA, lactate
Measured: Week 6
Secondary outcomes (3)
Gastrointestinal symptoms (incidence and severity)
Measured: Week 1, Week 3, Week 6, Week 8
Anthropometry
Measured: Week 1, Week 3, Week 6, Week 8
Number, type and severity of (serious) adverse events
Measured: Week 1, Week 3, Week 6, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Why it stopped: The study was withdrawn due to change of the study product formulation.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danone Global Research & Innovation Center
- Responsible party
- Sponsor
- Investigators
- Sungkom Jongpiputvanich, A/Prof., MD., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507935
- Sponsor's protocol ID
- COL.1.C/A
- Acronym
- ColoR
- Status last verified
- Sep 2012
- First submitted
- 5 Jan 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Prebiotic Oligosaccharides on Gut Microbiota Composition in Healthy Infants
- ClinicalTrials.gov ID
- NCT01507935
- Acronym / sponsor ID
- ColoR / COL.1.C/A
- Conditions
- Healthy Infants
- Keywords
- Healthy infants, Infant formula, Prebiotics oligosaccharides, Colonisation Resistance, Gut Microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn due to change of the study product formulation.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Danone Global Research & Innovation Center
- Study start
- Jan 2012
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 11 Jan 2012 (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.
This study is initiated to investigate the effect of infant formulas with added specific prebiotic oligosaccharides on the reduction of specific potential pathogens and/or toxins.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group I | Active comparator | Other: Regular non-hydrolysed cow's milkHealthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture I |
| Intervention Group II | Active comparator | Other: Regular non-hydrolysed cow's milkHealthy infants receiving regular non-hydrolysed cow's milk based infant formula with added prebiotic oligosaccharides mixture II |
| Control Group | Placebo comparator | Other: Regular non-hydrolysed cow's milkHealthy infants receiving regular non-hydrolysed cow's milk based infant formula with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides |
| Reference group | No intervention | –Exclusively breast-fed infants |
Who may qualify
- Ages
- 8 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy term infants (gestational age 37 to 42 weeks) aged 2-2.5 months at inclusion
- Fully formula fed for at least one week (not applicable for the breastfeeding reference group since these infants must be exclusively breastfed before and throughout the study)
- Parents' or guardian's written informed consent
Key exclusion criteria (8 listed)
- Being weaned before inclusion (introduction of any other foods other than formula or breast milk.)
- Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
- Disorders requiring a special diet (such as food intolerance or food allergy or complaints such as reflux, constipation and cramps)
- Significant congenital abnormality that could affect the study results
- Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks preceding the study
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 |
|---|---|---|
| Regular non-hydrolysed cow's milkRegular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I | Other | Intervention Group I |
| Regular non-hydrolysed cow's milkRegular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II | Other | Intervention Group II |
| Regular non-hydrolysed cow's milkRegular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides | Other | Control Group |
Primary outcome
Gut microbiota composition and its metabolic activity
Time frame: Week 6
* Gut microbiota composition: count and/or proportion and/or prevalence of group/genus/species of bacteria in the gut * Metabolic activity of the gut microbiota: pH, SCFA, lactate
3 secondary outcomes
Gastrointestinal symptoms (incidence and severity)
Time frame: Week 1, Week 3, Week 6, Week 8
Anthropometry
Time frame: Week 1, Week 3, Week 6, Week 8
Number, type and severity of (serious) adverse events
Time frame: Week 1, Week 3, Week 6, Week 8
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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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.
Sungkom Jongpiputvanich, A/Prof., MD. principal investigator
Chulalongkorn University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Regular non-hydrolysed cow's milk in people with Healthy Infants, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in Thailand.
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 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: withdrawn, as of the sponsor's last update on 5 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Gut microbiota composition and its metabolic activity (time frame: Week 6). 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 5 Sep 2012.