Effect of Probiotics on Infantile Colic Symptoms

ConditionInfantile Colic

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

AgeUp to 8

SponsorLallemand Health Solutions

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic
Dietary supplement
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.
Placebo
Dietary supplement
Participants will be taking 1 sachet a day, at a similar time every day, dissolved in 10 ml of lukewarm water.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: ProbioticExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in daily crying duration

Proportion of infants who experience a decrease of mean daily crying duration of at least 50% after 4 weeks of intervention, in placebo versus probiotic groups.

Time frame

4 weeks

Secondary outcomes

Change in crying patterns

Proportion of infants who experience a decrease of mean daily crying duration of at least 50% or at least 25%, mean daily number of crying episodes and variation in mean daily crying duration after 1, 2, 3, 4 weeks of intervention, in placebo versus probiotic groups.

Time frame

4 weeks

Change in sleep duration

Variation in the mean daily duration of the infant's sleep after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.

Time frame

4 weeks

Change in maternal quality of life

Variation in the maternal score of the mother quality-of-life questionnaire (SF- 36) after 4 weeks of intervention in probiotic versus placebo groups.

Time frame

4 weeks

Change in bowel habits

General perception of colic evolution (total recovery / better / worse / no change), infant bowel movement frequency (mean daily number of stools) and stool consistency (rate (%), Amsterdam infant stool scale) after 1, 2, 3, 4 weeks of intervention in probiotic versus placebo groups.

Time frame

4 weeks

Other outcomes

Safety and tolerability of the intervention

Assessment of the safety and tolerability of the probiotic formulation and the placebo through records of AEs/SAEs, growth parameters and number of unscheduled visits to the doctor.

Time frame

5 weeks

Change in fecal immune markers and proteins

Difference in the concentration of fecal immune markers and proteins after 4 weeks of intervention in probiotic versus placebo groups.

Time frame

4 weeks