Infantile ColicNCT03329222
An Infant Formula Trial on Dietary Management of Infantile Colic
A study testing Specific hydrolysed proteins and Standard cow's milk with prebiotics mixture in people with Infantile Colic, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.
Trial summary
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic. Read more about this study
- Who is it for?
- Ages 21 to 56 days
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Specific hydrolysed proteins and Standard cow's milk with prebiotics mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 27 Oct 2017to 3 Jul 2018
- 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 21 to 56 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 21-56 days (both inclusive);
- Gestation age 37-42 weeks;
- Normal birth weight for gestational age and gender
- 5-minute APGAR score >7;
- Diagnosed with infantile colic ;
- Fully formula fed for at least 7 days before randomisation;
- Written informed consent from the parent and/or legal representative.
Who cannot join
- Any plausible cause of inconsolable crying as judged by the investigator;
- Presence of non-functional vomiting or failure to thrive;
- Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition;
- Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes;
- Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations;
- Received any special formula (e.g. lactose-free, hydrolysed protein);
Show all 14Show fewer
- Received any of the following products/medication within 7 days before randomisation:
- Probiotics
- Systemic antibiotics
- Prokinetics
- Proton pump inhibitors
- Twins or triplets or other infant(s) <6 months of age living in the same household;
- Incapability of the parent(s) to comply with the study protocol or investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements;
- Current participation in another clinical study involving investigational or marketed products.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
Read the detailed description
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic.
The various time points of the outcome are:
V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)
- Conditions
- Infantile Colic
- Being tested
- Specific hydrolysed proteins, Standard cow's milk with prebiotics mixture
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific hydrolysed proteinsOther
An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
Standard cow's milk with prebiotics mixtureOther
Standard cow's milk with prebiotics mixture
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose Receives: Other: Specific hydrolysed proteins |
| Control group | Active comparator | Standard cow's milk with prebiotics mixture Receives: Other: Standard cow's milk with prebiotics mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily inconsolable crying time using data recorded on subject's diaries
Daily inconsolable crying time over 6 weeks
Measured: 6 weeks
Secondary outcomes (7)
Daily crying time using data recorded on subject's diaries
Daily crying time over 6 weeks of intervention
Measured: 6 weeks
Daily fussing time using data recorded on subject's diaries
Daily fussing time over 6 weeks of intervention
Measured: 6 weeks
Daily inconsolable fussing time using data recorded on subject's diaries
Daily inconsolable fussing time over 6 weeks of intervention
Measured: 6 weeks
Daily stool frequency using data recorded on subject's diaries
Daily stool frequency over 6 weeks of intervention
Measured: 6 weeks
Daily stool consistency using data recorded on subject's diaries
Daily stool consistency over 6 weeks of intervention
Measured: 6 weeks
The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Measured: 6 weeks
The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Gastrointestinal symptoms using the Infant gastrointestinal symptoms questionnaire during the 6-week intervention period
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start27 Oct 2017
- Primary completion3 Jul 2018
- Study completion3 Jul 2018
Why it stopped: slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies 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
- Model description
- Randomized, two arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Phramongkutklao College of Medicine and Hospital, Maharaj Nakorn Chiang Mai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03329222
- Sponsor's protocol ID
- EBB16SI06749
- Status last verified
- Sep 2018
- First submitted
- 3 Oct 2017
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Controlled, Multi-centre Study to Assess the Efficacy of an Infant Formula in the Dietary Management of Infantile Colic
- ClinicalTrials.gov ID
- NCT03329222
- Acronym / sponsor ID
- EBB16SI06749
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Danone Asia Pacific Holdings Pte, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- National University Hospital, Singapore, Phramongkutklao College of Medicine and Hospital, Maharaj Nakorn Chiang Mai Hospital
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 3 Jul 2018 (actual)
- First posted
- 1 Nov 2017 (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.
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
Detailed description
A randomised, double blind, controlled, multi-centre study to assess the efficacy of an infant formula in the dietary management of infantile colic.
The hypothesis of the study is that the test product, compared to the control formula, will reduce the crying time in infants with infantile colic.
The various time points of the outcome are:
V1 (screening : Day -5 to day 0); V2 ( Randomization: Day 0); V3 (Day 7); V4 (Day 21); Phone Call (Day 28); V5 (End -intervention: Day 42); V6 (Day 56)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, two arms
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Specific hydrolysed proteinsAn infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose |
| Control group | Active comparator | Other: Standard cow's milk with prebiotics mixtureStandard cow's milk with prebiotics mixture |
Who may qualify
- Ages
- 21 to 56 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants aged 21-56 days (both inclusive);
- Gestation age 37-42 weeks;
- Normal birth weight for gestational age and gender
- 5-minute APGAR score >7;
- Diagnosed with infantile colic ;
Key exclusion criteria (14 listed)
- Any plausible cause of inconsolable crying as judged by the investigator;
- Presence of non-functional vomiting or failure to thrive;
- Presence of any congenital defects in the gastrointestinal system or other defects preventing oral nutrition;
- Congenital condition and/or previous or current illness/infection and (or) medication use that could interfere with the main study outcomes;
- Known cow's milk protein allergy, lactose intolerance, or galactosaemia; including presence of any allergic manifestations;
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 |
|---|---|---|
| Specific hydrolysed proteinsAn infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose | Other | Intervention group |
| Standard cow's milk with prebiotics mixtureStandard cow's milk with prebiotics mixture | Other | Control group |
Primary outcome
Daily inconsolable crying time using data recorded on subject's diaries
Time frame: 6 weeks
Daily inconsolable crying time over 6 weeks
7 secondary outcomes
Daily crying time using data recorded on subject's diaries
Time frame: 6 weeks
Daily fussing time using data recorded on subject's diaries
Time frame: 6 weeks
Daily inconsolable fussing time using data recorded on subject's diaries
Time frame: 6 weeks
Daily stool frequency using data recorded on subject's diaries
Time frame: 6 weeks
Daily stool consistency using data recorded on subject's diaries
Time frame: 6 weeks
The frequency of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Time frame: 6 weeks
The intensity of subject's GI symptoms of digestion in the 7-day period prior to the visit using the Infant gastrointestinal symptoms questionnaire
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific hydrolysed proteins and Standard cow's milk with prebiotics mixture in people with Infantile Colic, run by Danone Asia Pacific Holdings Pte, Ltd. at 2 sites in 2 countries.
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 7 inclusion and 14 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: stopped early, as of the sponsor's last update on 10 Sep 2018. 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 Singapore, 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. 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 was stopped early (reason given: slow recruitment). Results are not available in the source record.
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?
Daily inconsolable crying time using data recorded on subject's diaries (time frame: 6 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 10 Sep 2018.