A Phase 2 interventional study of B. breve and B. breve plus L. fermentum in Infant Colic, sponsored by Mónica Olivares Martín; PhD. Completed at 1 site in Spain. Open to participants aged 3 Weeks to 12 Weeks. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Mónica Olivares Martín; PhD · Phase 2, Interventional, and Treatment
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 156 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →This is the only study on the registry with Mónica Olivares Martín; PhD as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Control group that will receive simethicone 4 times (10 drops) a day.
Drug: Simethicone 20 MG
Bifidobacterium probiotic strain at 1E+08 cfu/day
Probiotic combination at 2E+08 cfu/day
Standard treatment for infant colic
Crying time
Crying time in minutes per day
Time frame: 4 weeks
Responders to treatment on weeks 1, 2, 3 and 4
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
Time frame: 4 weeks
Gut microbiota
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.
Time frame: 4 weeks
Stool carbohydrates
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).
Time frame: 4 weeks
Ran from May 2017 to primary completion in Jun 2019, 24 months.
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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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