Not provided
Not provided
Not provided
Not provided
Never started
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| CRC CHI Creteil France | OTHER_GOV |
| Association Clinique Thérapeutique Infantile du val de Marne | OTHER |
| Hopital Universitaire Robert-Debre | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria. Forty breastfed infants aged from 29 days to 3 months will be enrolled and blinded randomized to receive orally L.reuteri or placebo. The rate of responders (reduction of daily crying time >50% compared to the baseline) will be assessed at day 7, day 14 and day 21 in both groups. The average daily crying time as well as the associated digestive symptoms will also be analyzed.
NOTE: The study never started.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactobacillus reteuri | Experimental | Dietary Supplement: Lactobacillus reuteri DSM17938 probiotic 2 x 10(8) CFU/day 21 days |
|
| Placebo | Placebo Comparator | Other: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM17938 probiotic | Dietary Supplement | Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion. |
| Measure | Description | Time Frame |
|---|---|---|
| The responder rate (infants for whom daily crying time decreases by 50% compared to baseline, D0) at D7 in the probiotic group compared to placebo. The daily crying time will be sound recorded during 24 hours at D0 and D7.and expressed in minutes. | day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The responders rates at D14 and D21 in the probiotic group compared to the placebo group. | Day 14 and day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| The average duration of crying in the probiotic group compared with the placebo group at D7, D14 and D21. | Day 7, 14 and 21 | |
| Gastrointestinal symptoms (constipation, diarrhea, flatulence) evaluated at each visit required by the protocol | day 7, 14 and 21 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Bellaiche, MD | Hopital Universitaire Robert-Debre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRC CHIC and ACTIV | Créteil | 94010 | France |
Not provided
| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics. |
|