The Effect of Probiotics on Symptoms of Infantile Colic

NCT05198700 | Withdrawn Phase 2

• 1 other identifier: L-022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Colic

Keywords

Infantile colic; Crying time; Probiotics; Sleep duration

Outcome Measures

Primary Outcomes (1)

• 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.

  5 weeks

Secondary Outcomes (9)

• Symptoms of infantile colic: Daily crying duration

  5 weeks

• Symptoms of infantile colic: Number of crying episodes

  5 weeks

• Symptoms of infantile colic: Sleep duration

  5 weeks

• Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time

  5 weeks

• Symptoms of infantile colic: Parental perception

  5 weeks

Other Outcomes (2)

• Fecal protein markers

  5 weeks

• Incidence of Adverse Events

  6 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants in this group will be randomized to receive the probiotic formulation for 4 weeks.

Dietary Supplement: Probiotic Formulation

Control Group

PLACEBO COMPARATOR

Participants in this group will be randomized to receive the placebo for 4 weeks.

Dietary Supplement: Placebo

Interventions

Probiotic Formulation DIETARY_SUPPLEMENT

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.

Experimental Group

Placebo DIETARY_SUPPLEMENT

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.

Control Group

Eligibility Criteria

• Age: Up to 8 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lallemand Health Solutions: lead
• ProbiSearch SL: collaborator

Study Sites (5)

Centro de Salud Cerro del Aire

Majadahonda, Madrid, 28220, Spain

Location

Centro de Salud Ibiza

Madrid, 28009, Spain

Location

Hospital Vithas La Milagrosa

Madrid, 28010, Spain

Location

Centro de Salud Campo de la Paloma

Madrid, 28018, Spain

Location

Hospital Vithas Aravaca

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

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

Study Officials

• Esther Jiménez Quintana, Ph.D.

  ProbiSearch SL

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: January 20, 2022
• Study Start: February 8, 2022
• Primary Completion: September 1, 2023
• Study Completion: February 1, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5)