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

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.

Study Overview

• Status: Recruiting
• Conditions: Colic
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Limosilactobacillus reuteri CCT 7862; Dietary supplement: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Santa Catarina
    • Criciuma, Santa Catarina, Brazil, 88806000
      • Recruiting
      • Monique Michels
      • Contact: monique michels, PhD; Phone Number: +5548996274651; Email: monique@biohall.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 3 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; product vehicle (sunflower oil)	Dietary supplement: Placebo; product vehicle (sunflower oil)
Experimental: Limosilactobacillus reuteri CCT 7862; Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ daY.	Dietary supplement: Limosilactobacillus reuteri CCT 7862; Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day.
Experimental: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863; Blend: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day.	Dietary supplement: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863; Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of probiotics strains by total daily crying time	Efficacy of probiotics strains by total daily crying time (minutes for day) recorded by parents daily	Change from baseline at three months
Efficacy of probiotics strains by total daily agitation time	Efficacy of probiotics strains by total daily agitation time (minutes for day) recorded by parents daily	Change from baseline at three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Efficacy of probiotics strains	Safety 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").	Change from baseline at three months
Safety and Efficacy of probiotics strains	Safety and Efficacy of probiotics strains by daily frequency evacuation and stool consistency (Bristol scale). There are seven types of stools (faeces) according to the Bristol Stool Chart. Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhoea and urgency.	Change from baseline at three months

Collaborators and Investigators

• Sponsor: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): January 5, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: January 6, 2023
• First Posted (Estimate): January 13, 2023

Study Record Updates

• Last Update Posted (Estimate): January 13, 2023
• Last Update Submitted That Met QC Criteria: January 6, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: probiotic; infant colic
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Colic
• Other Study ID Numbers: 63543922.2.0000.0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No