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Probiotics Strains for Infant Colic

Primary Purpose

Colic

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Limosilactobacillus reuteri CCT 7862
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863
Sponsored by
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colic focused on measuring infant colic, probiotic

Eligibility Criteria

17 Days - 23 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Monique MichelsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

Limosilactobacillus reuteri CCT 7862

Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863

Arm Description

product vehicle (sunflower oil)

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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").
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.

Full Information

First Posted
December 12, 2022
Last Updated
January 6, 2023
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
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1. Study Identification

Unique Protocol Identification Number
NCT05685030
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
January 5, 2023 (Actual)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
Keywords
infant colic, probiotic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase II randomized, placebo-controlled, triple-blind clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
product vehicle (sunflower oil)
Arm Title
Limosilactobacillus reuteri CCT 7862
Arm Type
Experimental
Arm Description
Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ daY.
Arm Title
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863
Arm Type
Experimental
Arm Description
Blend: Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
product vehicle (sunflower oil)
Intervention Type
Dietary Supplement
Intervention Name(s)
Limosilactobacillus reuteri CCT 7862
Intervention Description
Limosilactobacillus reuteri CCT 7862 - 1 x 10e9 UFC/ day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863
Intervention Description
Bifidobacterium lactis CCT 7858 + Lactobacillus rhamnosus CCT 7863 - 1 x 10e9 UFC/ day
Primary Outcome Measure Information:
Title
Efficacy of probiotics strains by total daily crying time
Description
Efficacy of probiotics strains by total daily crying time (minutes for day) recorded by parents daily
Time Frame
Change from baseline at three months
Title
Efficacy of probiotics strains by total daily agitation time
Description
Efficacy of probiotics strains by total daily agitation time (minutes for day) recorded by parents daily
Time Frame
Change from baseline at three months
Secondary Outcome Measure Information:
Title
Safety and Efficacy of probiotics strains
Description
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").
Time Frame
Change from baseline at three months
Title
Safety and Efficacy of probiotics strains
Description
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.
Time Frame
Change from baseline at three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Days
Maximum Age & Unit of Time
23 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Monique Michels
City
Criciuma
State/Province
Santa Catarina
ZIP/Postal Code
88806000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
monique michels, PhD
Phone
+5548996274651
Email
monique@biohall.com.br

12. IPD Sharing Statement

Plan to Share IPD
No

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Probiotics Strains for Infant Colic

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