Clinical trial NCT05685030: Probiotics Strains for Infant Colic
Official title: Evaluation of the Effectiveness of Probiotic Strains (L. Reuteri CCT 7862) and (B. Lactis CCT 7858 + L. Rhamnosus - CCT 7863) in Reducing Colic and Improving Gastrointestinal Health in Newborn
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colic
Keywords: infant colic
probiotic
Lead sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 180
Sex: ALL
Minimum age (years): 17
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II randomized, placebo-controlled, triple-blind clinical trial.
Primary purpose: PREVENTION

Brief summary: Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies.

Therefore, based on data in the literature, it is understood that there is evidence of the effectiveness of using probiotics, either alone or in the form of a blend, to alleviate the symptoms of infantile colic.

Detailed description: Infantile colic represents a self-limiting temporary condition, which occurs in about one in five babies in the first few months of life, and is characterized by inconsolable crying and fussiness of unknown cause. Despite its benign nature, infantile colic serves as a significant source of maternal anxiety and depression, impaired family functioning, and the most common reason for seeking medical advice in this age group. Infant colic is also associated with sleep problems in babies.

Parents and caregivers often seek medical attention for colic, including the use of medication, plant fiber, lactase, sucrose solution, hypoallergenic diet, and herbal tea. However, there is no single effective and safe intervention for infantile colic.

Interest in the use of probiotics as a potential treatment to reduce crying in babies with colic has increased lately. Recent studies have reported that the gut microbiota in infants with colic is characterized by lower proportions of Lactobacilli and Bifidobacteria and higher proportions of opportunistic proteobacteria (such as Escherichia coli, Enterobacter aerogenes and Klebsiella spp.) in comparison with the control babies. Thus, several researchers have suggested that probiotics may be useful in treating breastfed babies with colic and reducing crying time.

One study showed that administration of Lactobacillus reuteri DSM 17938 improved colic symptoms, although the effectiveness was only seen in breastfed and not formula fed infants. Another study showed that treatment with a combination of L. casei, L. rhamnosus, Streptococcus thermophilus, B. breve, L. acidophilus, B. infantiles, L. bulgaricus and fructooligosaccharides (FOS) reduced the duration of crying by almost 35 min compared to placebo. Furthermore, other authors has reported a reduced incidence of caregiver-reported colic when infants were supplemented with a combination of B. animalis subsp. lactis BB-12 and an unidentified strain of S. thermophilus, although colic was not formally diagnosed by a physician, which reduced the strength of the studies. A recent study on the same BB-12 strain overcame this deficiency by formally diagnosing colic using Rome-III criteria. However, this study showed that the response rate did not significantly improve over placebo until day 21. On the other hand, one study reported that the use of L. rhamnosus GG (ATCC53103) had no significant effect on crying in babies with colic. In another study, no significant differences were found in crying and irritability between the probiotic and placebo groups when supplemented with L. reuteri ATCC55730 or B. lactis BB-12.

Eligibility criteria: Inclusion Criteria:

* Age 20 days ± 3 days.
* Informed consent form signed by parents
* Both gender
* Availability to complete scales daily and answer phone calls and/or text messages.

Exclusion Criteria:

* Birth weight \<2500 g;
* current intake of antibiotics, prebiotics, or probiotics by the baby or mother;
* Children with known moderate or severe disease of any system (neural, skeletal, muscular, cutaneous, gastrointestinal, respiratory, genital, urinary, immune),
* parental difficulty in understanding study requirements as judged by physician.

Primary outcomes:
measure: Efficacy of probiotics strains by total daily crying time
timeFrame: Change from baseline at three months
measure: Efficacy of probiotics strains by total daily agitation time
timeFrame: Change from baseline at three months
Secondary outcomes:
measure: Safety and Efficacy of probiotics strains
timeFrame: Change from baseline at three months
measure: Safety and Efficacy of probiotics strains
timeFrame: Change from baseline at three months
Other outcomes:
Locations:
city: Criciuma
country: Brazil
facility: Monique Michels
state: Santa Catarina
Study officials:
References: