Beneficial Bacteria in GutNCT01813175

Color Synbiotics Study

A study testing Regular non-hydrolysed cow's milk I and Regular non-hydrolysed cow's milk II in people with Beneficial Bacteria in Gut, run by Danone Asia Pacific Holdings Pte, Ltd. at 3 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria. Read more about this study

Who is it for?: Ages 43 to 65 daysHealthy volunteers can take part
Conditions the study is for: Beneficial Bacteria in Gut
What is being tested?: Regular non-hydrolysed cow's milk I and Regular non-hydrolysed cow's milk II
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 290 participants
Where: 3 sitesThailand
Study dates: May 2013to Jul 2016
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 43 to 65 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
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 legal guardian's written informed consent

Who cannot join

Exclusion criteria for run-in period (visit 1, screening) are:
Being weaned before inclusion (introduction of any other foods other than formula or human milk)
Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
Use of systemic antibiotics or anti-mycotic drugs in the 4 weeks prior to entry into the study

Show all 10Show fewer

Received Inactivated Poliovirus Vaccine (IPV) or Rotavirus Vaccine (RV) prior to entry into the study
Gastroenteritis or diarrhoea in the last two weeks prior to entry into the study
Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

Trial locations and contacts

3 sites in 1 country.

Thailand3 sites

King Chulalongkorn Memorial Hospital
Bangkok
Phramongkutklao Hospital
Bangkok
Thammasat Hospital
Klong Luang, Changwat Pathum Thani

Other trials in Thailand

About this study

Official title: Randomised, Controlled, Double-blind Exploratory Study to Investigate the Effect of Specific Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.

This study is initiated to investigate the effect of infant formula with added specific synbiotics mixture on proportion of beneficial bacteria.

Conditions: Beneficial Bacteria in Gut
Being tested: Regular non-hydrolysed cow's milk I, Regular non-hydrolysed cow's milk II, Regular non-hydrolysed cow's milk - control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Regular non-hydrolysed cow's milk IOther
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Regular non-hydrolysed cow's milk IIOther
Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Regular non-hydrolysed cow's milk - controlOther
Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture

Study groups in NCT01813175
Study group	Role	What they receive
Intervention Group I	Active comparator	Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I Receives: Other: Regular non-hydrolysed cow's milk I
Interventional Group II	Active comparator	Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II Receives: Other: Regular non-hydrolysed cow's milk II
Control Group	Placebo comparator	Regular non-hydrolysed cow's milk based infant formula Receives: Other: Regular non-hydrolysed cow's milk - control
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.

Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
Measured: baseline, week 6

Secondary outcomes (2)

Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group
Measured: baseline, week 6
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group
Measured: baseline, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Jul 2016

First posted18 Mar 2013 (estimated)
Study startMay 2013
Primary completionJul 2016
Study completionJul 2016

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 Beneficial Bacteria in GutStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 290 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01813175
Sponsor's protocol ID: COL.1.C.A
Status last verified: Sep 2017
First submitted: 12 Mar 2013
Last updated: 7 Sep 2017
Results posted: No
Data monitoring committee: No

Publications

Phavichitr N, Wang S, Chomto S, Tantibhaedhyangkul R, Kakourou A, Intarakhao S, Jongpiputvanich S; COLOR Study Group; Roeselers G, Knol J. Impact of synbiotics on gut microbiota during early life: a randomized, double-blind study. Sci Rep. 2021 Feb 11;11(1):3534. doi: 10.1038/s41598-021-83009-2.
PubMed 33574421

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2017. 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 Synbiotics Mixtures on Gut Microbiota Composition in Healthy Infants.
ClinicalTrials.gov ID: NCT01813175
Acronym / sponsor ID: COL.1.C.A
Conditions: Beneficial Bacteria in Gut
Study type: Interventional
Recruitment status: Completed
Enrolment: 290 participants (actual)
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 18 Mar 2013 (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 formula with added specific synbiotics mixture on proportion of beneficial bacteria.

Study design

Primary purpose: Other
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 milk IRegular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
Interventional Group II	Active comparator	Other: Regular non-hydrolysed cow's milk IIRegular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
Control Group	Placebo comparator	Other: Regular non-hydrolysed cow's milk - controlRegular non-hydrolysed cow's milk based infant formula
Reference Group	No intervention	–Exclusively breast-fed infants

Who may qualify

Ages: 43 to 65 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy term infants (gestational age ≥ 37 1/7 and ≤ 41 6/7 weeks) aged 46 - 65 days (inclusive) at entry into the study
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 legal guardian's written informed consent

Key exclusion criteria (10 listed)

Exclusion criteria for run-in period (visit 1, screening) are:
Being weaned before inclusion (introduction of any other foods other than formula or human milk)
Moderate or severe acute malnutrition, defined as weight-for-age and sex below -2 z-scores of the median WHO growth standards
Medical condition for which a special diet other than standard (non hydrolised) cow's milk-based infant formula is required
Known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement

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 milk IRegular non-hydrolysed cow's milk based infant formula with synbiotics mixture I	Other	Intervention Group I
Regular non-hydrolysed cow's milk IIRegular non-hydrolysed cow's milk based infant formula with synbiotics mixture II	Other	Interventional Group II
Regular non-hydrolysed cow's milk - controlRegular non-hydrolysed cow's milk based infant formula without synbiotics mixture	Other	Control Group

Primary outcome

Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group
Time frame: baseline, week 6

2 secondary outcomes

Change of proportion of baseline beneficial bacteria at week 6 in interventional group I compared to the change in control group
Time frame: baseline, week 6
Change of Baseline proportion of beneficial bacteria at week 6 in interventional group II compared to the change in control group
Time frame: baseline, week 6

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 7 Sep 2017.
Derived from this study: PubMed 33574421Phavichitr N, Wang S, Chomto S, Tantibhaedhyangkul R, Kakourou A, Intarakhao S, Jongpiputvanich S; COLOR Study Group; Roeselers G, Knol J. Impact of synbiotics on gut microbiota during early life: a randomized, double-blind study. Sci Rep. 2021 Feb 11;11(1):3534. doi: 10.1038/s41598-021-83009-2.

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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

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?

Change of Baseline proportion of beneficial bacteria at week 6 in interventional group compared to the change in control group (time frame: baseline, week 6). 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 NCT01813175, 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 7 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.