The Effect of Probiotics on Symptoms of Infantile Colic

Colic Clinical Trial

— PROCOLIN  

Official title:

The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05198700
• Other study ID #: L-022
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 8, 2022
• Est. completion date: February 2024

Study information

• Verified date: February 2023
• Source: Lallemand Health Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 8 Weeks

Eligibility

Inclusion Criteria:

1. Healthy male or female.

2. Age = 8 weeks old.

3. 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.

4. Exclusively breastfeeding and planning to breastfeed for duration of study.

5. With a written informed consent signed by the father, mother, or legal guardian, and with expressed or implied consent of the other parent.

6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and telephone calls.

Exclusion Criteria:

1. Birthweight < 2500 g.

2. Gestational age < 37 weeks.

3. Apgar score at 5 minutes < 7.

4. Partially or fully formula fed infants, with the exception of the first 4 days after birth.

5. Stunted growth/weight loss (< 100 g/week from birth to last reported).

6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases or gastrointestinal malformations.

7. Fever and/or infectious diseases, or current systemic infections, or history of congenital infections.

8. Genetic diseases and chromosomal abnormalities.

9. Metabolic diseases or pancreatic insufficiency.

10. Immunodeficiency.

11. Neurological diseases.

12. Suspected or confirmed food allergies and intolerances.

13. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening.

14. Use of anti-colic medication at any time from birth to the moment of screening.

15. Use of probiotic supplements by the mother between the birth of their infant and the moment of screening.

16. Currently enrolled in another clinical study or having participated in another clinical trial from birth to the moment of screening.

Related Conditions & MeSH terms

• Colic

Intervention

Dietary Supplement:
• Probiotic Formulation
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.
• Placebo
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.

Locations

Country	Name	City	State
Spain	Centro de Salud Campo de la Paloma	Madrid
Spain	Centro de Salud Ibiza	Madrid
Spain	Hospital Vithas Aravaca	Madrid
Spain	Hospital Vithas La Milagrosa	Madrid
Spain	Centro de Salud Cerro del Aire	Majadahonda	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Lallemand Health Solutions	ProbiSearch SL

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fecal protein markers	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.	5 weeks
Other	Incidence of Adverse Events	Comparison of the number of adverse events (AEs) and serious adverse events (SAEs) recorded in the probiotic and placebo groups.	6 weeks
Primary	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	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks
Secondary	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.	5 weeks