Infant Colic Treatment With Probiotics
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03467334|
Recruitment Status : Completed
First Posted : March 16, 2018
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Infant Colic||Dietary Supplement: B. breve Dietary Supplement: B. breve plus L. fermentum Drug: Simethicone 20 MG||Phase 2|
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic.
The objective of the present study is to compare the effect of B. brevis and B. brevis\L mixture. fermentum with respect to simethicone.
It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||156 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).|
|Official Title:||Nutritional Intervention, Multicenter, Randomized, Blind, Parallel Groups Study to Assess the Effect of Consumption of Bifidobacterium Breve CECT7263 and Lactobacillus Fermentum CECT5716 on Infant Colic|
|Actual Study Start Date :||May 31, 2017|
|Actual Primary Completion Date :||June 15, 2019|
|Actual Study Completion Date :||June 15, 2019|
Experimental: B. breve
Group that will receive B. breve CECT7263 one dose per day in a capsule to open and suspend the powder in infant milk or water.
Dietary Supplement: B. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day
Experimental: B. breve plus L. fermentum
Group that will receive B. breve CECT7263 and L. fermentum CECT5716 in one dose per day in a capsule to open and suspend the powder in infant milk or water.
Dietary Supplement: B. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day
Active Comparator: Simethicone 20 mg
Control group that will receive simethicone 4 times (10 drops) a day.
Drug: Simethicone 20 MG
Standard treatment for infant colic
- Crying time [ Time Frame: 4 weeks ]Crying time in minutes per day
- Responders to treatment on weeks 1, 2, 3 and 4 [ Time Frame: 4 weeks ]Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline
- Gut microbiota [ Time Frame: 4 weeks ]Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR.
- Stool carbohydrates [ Time Frame: 4 weeks ]Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467334
|Servicio Andaluz de Salud|
|Granada, Spain, 10012|
|Principal Investigator:||José Maldonado, MD, PhD||Specialist in Pediatrics of the Medical-Surgical UGC of Infancy of the University Hospital Complex of Granada (Spain)|