GrowthPhase 3NCT00929292
Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic
A Phase 3 study testing Modilac Dahlia 1 and Modilac 1 in people with Growth and Colic, run by Sodilac at 12 sites in France.
Trial summary
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula. Read more about this study
- Who is it for?
- Ages 3 weeks to 3 months
- What is being tested?
- Modilac Dahlia 1 and Modilac 1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 12 sitesFrance
- Study dates
- Nov 2006to Jul 2008
- Phase
- Phase 3
- 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 3 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy term infants with a gestational age ranging from 37 to 42 weeks
- Non breastfed children
- Infants with normal growth
- Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
- These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
- Apgar score > 5 to 7 minutes
Who cannot join
- Infants with severe regurgitations
- Newborn currently participating in another trial
- Infants presenting a metabolic, nervous or organic disease able to interfere with the study
- Infants presenting lactose intolerance
- Evidence of protein cow's milk allergy
- Mother who wants to keep breasfeeding
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Dr Francine Gressin-Cohen
Antony, 92160
Hôpital privé d'Antony
Antony, 92166
Hôpital Robert Ballanger
Aulnay-sous-Bois, 93602
Dr Brigitte Pacault
Boulogne-Billancourt, 92100
Dr Michel Dogneton
Boulogne-Billancourt, 92100
Dr Nassira Belaroussi Maamri
Boulogne-Billancourt, 92100
Dr KALINDJIAN
Issy-les-Moulineaux, 92130
Groupe Hospitalier de l'Institut Catholique de Lille (GHICL)
Lille, 59020
Dr Christophe Grillon
Meaux, 77100
Dr COUPRIE Claire
Paris, 75013
Dr RONZIER Monique
Paris, 75015
Dr Locquet André
Roncq, 59223
About this study
Official title: Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.
The purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
Read the detailed description
This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.
Both parents provided informed written consent.
- Being tested
- Modilac Dahlia 1, Modilac 1
- Keywords
- Infant formula, Alpha-lactalbumin, Protein composition, Colic, Probiotics
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modilac Dahlia 1Other
Also called Dahlia
Infant formula used for non breastfed children with colic
Modilac 1Other
Also called Modilac
Infant formula used for non breastfed children
| Study group | Role | What they receive |
|---|---|---|
| Modilac Dahlia 1 | Experimental | Formula enriched with alpha-lactalbumin and containing a probiotic Receives: Other: Modilac Dahlia 1 |
| Modilac 1 | Placebo comparator | Regular milk Receives: Other: Modilac 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying duration per 24 hours
Measured: 1 day before the first consumption ; 3 days before days 15 and 30
Secondary outcomes (8)
Growth Parameters
Measured: Day 30
Clinical Tolerance
Measured: 3 days before days 15 and 30
Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)
Measured: Durind the 15 first days of the diet and during the 15 last days of the diet
Number of regurgitations per day
Measured: 3 days before days 15 and 30
Gas and abdominal distensions
Measured: 3 days before days 15 and 30
Necessary Additive treatments
Measured: 3 days before days 15 and 30
Parents' satisfaction
Measured: Days 15 and 30
Agitation/Restlessness Period Duration
Measured: 3 days before days 15 and 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2009 (estimated)
- Study startNov 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sodilac
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christophe Dupont, PhD, Principal investigator, Hôpital Saint Vincent de Paul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929292
- Sponsor's protocol ID
- DAH-CL3-001
- Status last verified
- Jun 2009
- First submitted
- 26 Jun 2009
- Last updated
- 29 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Growth and Gastrointestinal Tolerance of an Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic.
- ClinicalTrials.gov ID
- NCT00929292
- Acronym / sponsor ID
- DAH-CL3-001
- Keywords
- Infant formula, Alpha-lactalbumin, Protein composition, Colic, Probiotics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- SodilacIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jun 2009 (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 purpose of this study is to evaluate the nutritional adequacy, the digestive tolerance and the effect on colic of an alpha-lactalbumin-enriched and probiotic-supplemented infant formula.
Detailed description
This double-blind, placebo-controlled study was undertaken with 66 healthy infants with colic, aged 3 weeks to 3 months, fed a month either with the experimental formula (EF) or with the control formula (CF) and evaluated for efficacy and safety parameters at days 15 and 30.
Both parents provided informed written consent.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modilac Dahlia 1 | Experimental | Other: Modilac Dahlia 1Formula enriched with alpha-lactalbumin and containing a probiotic |
| Modilac 1 | Placebo comparator | Other: Modilac 1Regular milk |
Who may qualify
- Ages
- 3 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy term infants with a gestational age ranging from 37 to 42 weeks
- Non breastfed children
- Infants with normal growth
- Infants presenting colic defined as crying periods at least 3 hours per days, 3 days per weeks, for more than 3 weeks
- These crying periods could be associated with other digestive troubles(gas, abdominal distensions, regurgitations)
Key exclusion criteria (6 listed)
- Infants with severe regurgitations
- Newborn currently participating in another trial
- Infants presenting a metabolic, nervous or organic disease able to interfere with the study
- Infants presenting lactose intolerance
- Evidence of protein cow's milk allergy
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 |
|---|---|---|
| Modilac Dahlia 1Also: DahliaInfant formula used for non breastfed children with colic | Other | Modilac Dahlia 1 |
| Modilac 1Also: ModilacInfant formula used for non breastfed children | Other | Modilac 1 |
Primary outcome
Crying duration per 24 hours
Time frame: 1 day before the first consumption ; 3 days before days 15 and 30
8 secondary outcomes
Growth Parameters
Time frame: Day 30
Clinical Tolerance
Time frame: 3 days before days 15 and 30
Number of therapeutic failures (no diminution in the intensity or the frequency of the digestive symptoms)
Time frame: Durind the 15 first days of the diet and during the 15 last days of the diet
Number of regurgitations per day
Time frame: 3 days before days 15 and 30
Gas and abdominal distensions
Time frame: 3 days before days 15 and 30
Necessary Additive treatments
Time frame: 3 days before days 15 and 30
Parents' satisfaction
Time frame: Days 15 and 30
Agitation/Restlessness Period Duration
Time frame: 3 days before days 15 and 30
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 29 Jun 2009.
Related trials for Growth
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
RecruitingPhase 3
Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 1/2
A Study of VRN110755 in Patients With EGFR-Mutant Non-Small Cell Lung Cancer
EGFR-Mutant Non-Small Cell Lung Cancer
Active, not recruitingPhase 2
Safety, Preliminary Effectiveness of BNT327, an Investigational Therapy for Patients With Small-cell Lung Cancer in Combination With Chemotherapy
Extensive-stage Small-cell Lung Cancer, Small-cell Lung Cancer
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.
Christophe Dupont, PhD principal investigator
Hôpital Saint Vincent de Paul
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modilac Dahlia 1 and Modilac 1 in people with Growth and Colic, run by Sodilac at 12 sites in France.
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 6 inclusion and 6 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 29 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Crying duration per 24 hours (time frame: 1 day before the first consumption ; 3 days before days 15 and 30). 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 29 Jun 2009.