Effect of Probiotics on Infantile Colic Symptoms

Recruiting Phase 2 Interventional Study
Infantile Colic
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
Up to 8 Weeks
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
70 (estimated)
Sponsor
Lallemand Health Solutions · Industry
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About This Trial

The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days. I4. Exclusively breastfeeding and planning to breastfeed f…
Contacts

Lya Blais, M.Sc.

+ 1-514-283-1387

lblais@lallemand.com

CONTACT

Basile Frilley

epic-oc@biofortis.fr

CONTACT