Probiotics Strains for Infant Colic

NCT05685030 | Unknown Phase 2 DMC

• 1 other identifier: 63543922.2.0000.0119
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Colic

Keywords

infant colic; probiotic

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Safety and Efficacy of probiotics strains

  Change from baseline at three months

• Safety and Efficacy of probiotics strains

  Change from baseline at three months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

product vehicle (sunflower oil)

Dietary Supplement: Placebo

Limosilactobacillus reuteri CCT 7862

EXPERIMENTAL

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

Dietary Supplement: Limosilactobacillus reuteri CCT 7862

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

EXPERIMENTAL

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

Dietary Supplement: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

Interventions

Placebo DIETARY_SUPPLEMENT

product vehicle (sunflower oil)

Placebo

Limosilactobacillus reuteri CCT 7862 DIETARY_SUPPLEMENT

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

Limosilactobacillus reuteri CCT 7862

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 DIETARY_SUPPLEMENT

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

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

Eligibility Criteria

• Age: 17 Days - 23 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Monique Michels

Criciúma, Santa Catarina, 88806000, Brazil

RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 13, 2023
• Study Start: January 5, 2023
• Primary Completion: January 5, 2023
• Study Completion: July 30, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)