Skip to content

Probiotics Strains for Infant Colic

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05685030
Enrollment
180
Registered
2023-01-13
Start date
2023-01-05
Completion date
2023-07-30
Last updated
2023-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colic

Keywords

infant colic, probiotic

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.

Interventions

DIETARY_SUPPLEMENTPlacebo

product vehicle (sunflower oil)

DIETARY_SUPPLEMENTLimosilactobacillus reuteri CCT 7862

Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day.

DIETARY_SUPPLEMENTBifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day

Sponsors

Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Phase II randomized, placebo-controlled, triple-blind clinical trial.

Eligibility

Sex/Gender
ALL
Age
17 Days to 23 Days
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of probiotics strains by total daily crying timeChange from baseline at three monthsEfficacy of probiotics strains by total daily crying time (minutes for day) recorded by parents daily
Efficacy of probiotics strains by total daily agitation timeChange from baseline at three monthsEfficacy of probiotics strains by total daily agitation time (minutes for day) recorded by parents daily

Secondary

MeasureTime frameDescription
Safety and Efficacy of probiotics strainsChange from baseline at three monthsSafety and Efficacy of probiotics strains by baby sleep duration (minutes for day) and and sleep quality through scale recorded by parents daily. This Score use a four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = few, 1 = some- times, 2 = often, and 3 = almost always).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026