Infantile ColicCocoNCT01721850
Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic
A study testing intervention formula 1 and intervention formula 2 in people with Infantile Colic, run by HiPP GmbH & Co. Vertrieb KG at 18 sites in 2 countries.
Trial summary
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic. Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula. Read more about this study
- Who is it for?
- Ages 15 to 60 daysHealthy volunteers can take part
- Conditions the study is for
- Infantile Colic
- What is being tested?
- intervention formula 1 and intervention formula 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Dec 2011to Apr 2019
- 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 15 to 60 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy term infants
- Subjects appropriate for gestational age between 35 and 41 weeks
- Subjects between 15-60 days old
- Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
- Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
- Subjects exclusively bottle-fed at study entrance
- Day care of the child only by mother/father
- Provide written informed consent in accordance with legal requirement
Who cannot join
- Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
- Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
- Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
- Subjects receiving formula for special medical purposes
- Exclusively breast-fed infants
- Feeding of supplemental Pro- and/or Prebiotics two weeks prior to inclusion
- Allergic diseases (manifest atopic dermatitis, cow's milk allergy)
- Participation in any other clinical intervention
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Italy15 sites
Pediatric office
Alba, Piedmont, 10141
Pediatric office
Borgone, Piedmont, 10053
Pediatric office
Carmagnola, Piedmont, 10022
Pediatric Office
Condove, Piedmont, 10055
Pediatric office
Mondovì, Piedmont, 10090
Pediatric office
San Mauro Torinese, Piedmont, 10099
Pediatric office
Turin, Piedmont, 10078
Pediatric office
Turin, Piedmont, 10124
Pediatric office
Turin, Piedmont, 10126
Pediatric Office
Turin, Piedmont, 10132
Pediatric Office
Turin, Piedmont, 10137
Pediatric office
Turin, Piedmont, 10148
Pediatric office
Turin, Piedmont, 10149
Pediatric Office
Volpiano, Piedmont, 10088
Pediatric Office
Volvera, Piedmont, 10040
Germany3 sites
Pediatric Office
Düsseldorf, 40223
Pediatric Office
Kehl, 77694
Pediatric Office
Mülheim, 45475
About this study
Official title: Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
- Conditions
- Infantile Colic
- Being tested
- control formula, intervention formula 1, intervention formula 2
- Keywords
- infant nutrition, infantile colic
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control formulaOther
commercial stage 1 infant formula
intervention formula 1Other
infant formula with hydrolyzed protein (type I) and pre- and probiotics
intervention formula 2Other
infant formula with hydrolyzed protein (type II) and pre- and probiotics
| Study group | Role | What they receive |
|---|---|---|
| control formula | Active comparator | infants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol Receives: Other: control formula |
| intervention formula 1 group | Experimental | infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol Receives: Other: intervention formula 1 |
| intervention formula 2 group | Experimental | infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol Receives: Other: intervention formula 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
daily total crying time
evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
Measured: 28 days
Secondary outcomes (4)
growth parameters
determination of body weight, length, head circumference
Measured: 90 days
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
stool characteristics: frequency, consistency and color; gastrointestinal disorders: regurgitation, obstipation; side effects: vomiting, diarrhea, skin reactions
Measured: 28 days
formula intake
evaluation of average daily drinking amount and formula acceptance
Measured: 28 days
intestinal microbiota
evaluation of changes in the composition of the intestinal microbiota (Lactobacilli, Bifidobacteria, Coliforms) after intervention
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startDec 2011
- Primary completionApr 2019
- Study completionApr 2019
Why it stopped: Trial insurance could not be prolonged any more and expired
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francesco Savino, Dr., Principal investigator, Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721850
- Sponsor's protocol ID
- HiPP-505092
- Acronym
- Coco
- Status last verified
- Jan 2022
- First submitted
- 30 Oct 2012
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of New Infant Formula and Its Effects on the Gastrointestinal Tolerance (Crying Time) in Infantile Colic: a Double-blind, Randomized, Controlled Intervention Study
- ClinicalTrials.gov ID
- NCT01721850
- Acronym / sponsor ID
- Coco / HiPP-505092
- Conditions
- Infantile Colic
- Keywords
- infant nutrition, infantile colic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial insurance could not be prolonged any more and expired
- Enrolment
- 169 participants (actual)
- Lead sponsor
- HiPP GmbH & Co. Vertrieb KGIndustry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 6 Nov 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.
The study is conducted to examine the safety and efficacy of a new infant formula and its effects on the gastrointestinal tolerance in infants suffering from colic.
Primary hypothesis to be tested is: an infant formula with optimized composition improves colicky symptoms compared to a standard formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control formula | Active comparator | Other: control formulainfants are fed a commercial stage 1 infant formula during the first 4 months of life, according to protocol |
| intervention formula 1 group | Experimental | Other: intervention formula 1infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol |
| intervention formula 2 group | Experimental | Other: intervention formula 2infants are fed hydrolyzed infant formula containing pre- and probiotics during the first 4 months of life, according to protocol |
Who may qualify
- Ages
- 15 to 60 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy term infants
- Subjects appropriate for gestational age between 35 and 41 weeks
- Subjects between 15-60 days old
- Subjects with birth weight between 2500 and 4200 g and regular weight gain (≥150g / week)
- Diagnosis of infantile colic according to modified Wessel criteria (Crying episodes lasting 3 or more hours/day and occurring at least 3 days/week for at least 1 week)
Key exclusion criteria (8 listed)
- Neonatal problems (respiratory distress, asphyxia, Hypoglycaemia, sepsis, NEC)
- Clinical evidence of chronic illness or gastrointestinal disorders (GER, gastroenteritis)
- Assumption of any kind of medication (except vitamin D, vitamin K and fluoride prophylaxis) during the week before the beginning of the study and during the study period
- Subjects receiving formula for special medical purposes
- Exclusively breast-fed infants
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 |
|---|---|---|
| control formulacommercial stage 1 infant formula | Other | control formula |
| intervention formula 1infant formula with hydrolyzed protein (type I) and pre- and probiotics | Other | intervention formula 1 group |
| intervention formula 2infant formula with hydrolyzed protein (type II) and pre- and probiotics | Other | intervention formula 2 group |
Primary outcome
daily total crying time
Time frame: 28 days
evaluation of the difference in the average reduction of daily crying time after 28 days of intervention between treatment and control group
4 secondary outcomes
growth parameters
Time frame: 90 days
tolerance evaluated by stool characteristics, gastrointestinal disorders and side effects
Time frame: 28 days
formula intake
Time frame: 28 days
intestinal microbiota
Time frame: 0-28 days
Results and safety
The study was stopped early (reason given: Trial insurance could not be prolonged any more and expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
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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.
Francesco Savino, Dr. principal investigator
Ospedale Infantile Regina Margherita, Dipartimento di Scienze Pediatriche e dell'Adolescenza.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intervention formula 1 and intervention formula 2 in people with Infantile Colic, run by HiPP GmbH & Co. Vertrieb KG at 18 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 8 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: stopped early, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Italy, Germany. 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: Trial insurance could not be prolonged any more and expired). 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 total crying time (time frame: 28 days). 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 20 Jan 2022.