Back to resultsThe Effect of Probiotics on Symptoms of Infantile Colic (PROCOLIN)
Primary Purpose
Colic
Status
Withdrawn
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Probiotic Formulation
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Colic focused on measuring Infantile colic, Crying time, Probiotics, Sleep duration
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female.
- Age ≤ 8 weeks old.
- Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
- Exclusively breastfeeding and planning to breastfeed for duration of study.
- With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
- With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.
Exclusion Criteria:
- Birthweight < 2500 g.
- Gestational age < 37 weeks.
- Apgar score at 5 minutes < 7.
- Partially or fully formula fed infants, with the exception of the first 4 days after birth.
- Stunted growth/weight loss (< 100 g/week from birth to last reported).
- Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
- Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- Genetic diseases and chromosomal abnormalities.
- Metabolic diseases or pancreatic insufficiency.
- Immunodeficiency.
- Neurological diseases.
- Suspected or confirmed food allergies and intolerances.
- Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
- Use of anti-colic medication at any time from birth to the moment of screening.
- Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
- Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
Sites / Locations
- Centro de Salud Cerro del Aire
- Centro de Salud Ibiza
- Hospital Vithas La Milagrosa
- Centro de Salud Campo de la Paloma
- Hospital Vithas Aravaca
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Participants in this group will be randomized to receive the probiotic formulation for 4 weeks.
Participants in this group will be randomized to receive the placebo for 4 weeks.
Outcomes
Primary Outcome Measures
Symptoms of infantile colic
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Secondary Outcome Measures
Symptoms of infantile colic: Daily crying duration
Comparison of the average change from baseline in the mean daily crying duration between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Symptoms of infantile colic: Number of crying episodes
Comparison of the change in the number of crying episodes from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Symptoms of infantile colic: Sleep duration
Comparison of the difference in sleep duration from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
Comparison of the difference in time to reach a 25 percent and 50 percent improvement in cry/fuss time from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Symptoms of infantile colic: Parental perception
Comparison of the difference in the perceived evolution of colic symptoms by parents of participants in the probiotic and placebo groups, as assessed by questions about the evolution of colic symptoms at visits 2 and 4.
Change in the mother's quality of life
Comparison of the changes in the overall score of the SF-36 from baseline (0 to 100; a higher score corresponds to a better quality of life), between mothers of participants in the probiotic and placebo groups.
Bowel movement frequency
Comparison of the changes in bowel movement frequency and consistency from baseline between the probiotic and placebo groups, as assessed by the Amsterdam Infant Stool Scale.
Fecal strain recovery of the probiotic
Presence of the probiotic strain in participants in the probiotic group, as determined by qPCR analysis of stool samples collected at baseline and at week 4.
Fecal microbiome composition
Comparison of the differences in the composition of fecal microbiota and mycobiota between the probiotic and placebo groups, as determined by 16S sequencing of stool samples collected at baseline and at week 4.
Full Information
NCT ID
NCT05198700
First Posted
December 3, 2021
Last Updated
June 28, 2023
Sponsor
Lallemand Health Solutions
Collaborators
ProbiSearch SL
1. Study Identification
Unique Protocol Identification Number
NCT05198700
Brief Title
The Effect of Probiotics on Symptoms of Infantile Colic
Acronym
PROCOLIN
Official Title
The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Null recruitment
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lallemand Health Solutions
Collaborators
ProbiSearch SL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
Detailed Description
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period.
The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colic
Keywords
Infantile colic, Crying time, Probiotics, Sleep duration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants in this group will be randomized to receive the probiotic formulation for 4 weeks.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will be randomized to receive the placebo for 4 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic Formulation
Intervention Description
Participants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Participants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption.
Primary Outcome Measure Information:
Title
Symptoms of infantile colic
Description
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Symptoms of infantile colic: Daily crying duration
Description
Comparison of the average change from baseline in the mean daily crying duration between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time Frame
5 weeks
Title
Symptoms of infantile colic: Number of crying episodes
Description
Comparison of the change in the number of crying episodes from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time Frame
5 weeks
Title
Symptoms of infantile colic: Sleep duration
Description
Comparison of the difference in sleep duration from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time Frame
5 weeks
Title
Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
Description
Comparison of the difference in time to reach a 25 percent and 50 percent improvement in cry/fuss time from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time Frame
5 weeks
Title
Symptoms of infantile colic: Parental perception
Description
Comparison of the difference in the perceived evolution of colic symptoms by parents of participants in the probiotic and placebo groups, as assessed by questions about the evolution of colic symptoms at visits 2 and 4.
Time Frame
5 weeks
Title
Change in the mother's quality of life
Description
Comparison of the changes in the overall score of the SF-36 from baseline (0 to 100; a higher score corresponds to a better quality of life), between mothers of participants in the probiotic and placebo groups.
Time Frame
5 weeks
Title
Bowel movement frequency
Description
Comparison of the changes in bowel movement frequency and consistency from baseline between the probiotic and placebo groups, as assessed by the Amsterdam Infant Stool Scale.
Time Frame
5 weeks
Title
Fecal strain recovery of the probiotic
Description
Presence of the probiotic strain in participants in the probiotic group, as determined by qPCR analysis of stool samples collected at baseline and at week 4.
Time Frame
5 weeks
Title
Fecal microbiome composition
Description
Comparison of the differences in the composition of fecal microbiota and mycobiota between the probiotic and placebo groups, as determined by 16S sequencing of stool samples collected at baseline and at week 4.
Time Frame
5 weeks
Other Pre-specified Outcome Measures:
Title
Fecal protein markers
Description
Comparison of the differences in the concentration of fecal protein markers between probiotic and placebo groups in stool samples collected at baseline and at week 4. Proteins will be quantified using immunoassay methods.
Time Frame
5 weeks
Title
Incidence of Adverse Events
Description
Comparison of the number of adverse events (AEs) and serious adverse events (SAEs) recorded in the probiotic and placebo groups.
Time Frame
6 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
8 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy male or female.
Age ≤ 8 weeks old.
Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behaviour for 3 or more hours per day, during 3 or more days in 7 days.
Exclusively breastfeeding and planning to breastfeed for duration of study.
With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.
With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.
Exclusion Criteria:
Birthweight < 2500 g.
Gestational age < 37 weeks.
Apgar score at 5 minutes < 7.
Partially or fully formula fed infants, with the exception of the first 4 days after birth.
Stunted growth/weight loss (< 100 g/week from birth to last reported).
Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.
Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
Genetic diseases and chromosomal abnormalities.
Metabolic diseases or pancreatic insufficiency.
Immunodeficiency.
Neurological diseases.
Suspected or confirmed food allergies and intolerances.
Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.
Use of anti-colic medication at any time from birth to the moment of screening.
Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.
Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Jiménez Quintana, Ph.D.
Organizational Affiliation
ProbiSearch SL
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Salud Cerro del Aire
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28220
Country
Spain
Facility Name
Centro de Salud Ibiza
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Vithas La Milagrosa
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
Centro de Salud Campo de la Paloma
City
Madrid
ZIP/Postal Code
28018
Country
Spain
Facility Name
Hospital Vithas Aravaca
City
Madrid
ZIP/Postal Code
28023
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
Learn more about this trial
The Effect of Probiotics on Symptoms of Infantile Colic
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