Clinical trial NCT05198700: The Effect of Probiotics on Symptoms of Infantile Colic
Official title: The Effect of a Probiotic on Symptoms of Infantile Colic: a Randomized, Double-blind, Placebo-controlled Study (PROCOLIN)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colic
Keywords: Infantile colic
Crying time
Probiotics
Sleep duration
Lead sponsor: Lallemand Health Solutions
Sponsor class: INDUSTRY
Collaborators: name: ProbiSearch SL
First posted: 2022-01-20
Enrollment: 0
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Symptoms of infantile colic
timeFrame: 5 weeks
Secondary outcomes:
measure: Symptoms of infantile colic: Daily crying duration
timeFrame: 5 weeks
measure: Symptoms of infantile colic: Number of crying episodes
timeFrame: 5 weeks
measure: Symptoms of infantile colic: Sleep duration
timeFrame: 5 weeks
measure: Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
timeFrame: 5 weeks
measure: Symptoms of infantile colic: Parental perception
timeFrame: 5 weeks
measure: Change in the mother's quality of life
timeFrame: 5 weeks
measure: Bowel movement frequency
timeFrame: 5 weeks
measure: Fecal strain recovery of the probiotic
timeFrame: 5 weeks
measure: Fecal microbiome composition
timeFrame: 5 weeks
Other outcomes:
measure: Fecal protein markers
timeFrame: 5 weeks
measure: Incidence of Adverse Events
timeFrame: 6 weeks
Locations:
city: Majadahonda
country: Spain
facility: Centro de Salud Cerro del Aire
state: Madrid
city: Madrid
country: Spain
facility: Centro de Salud Ibiza
city: Madrid
country: Spain
facility: Hospital Vithas La Milagrosa
city: Madrid
country: Spain
facility: Centro de Salud Campo de la Paloma
city: Madrid
country: Spain
facility: Hospital Vithas Aravaca
Study officials:
affiliation: ProbiSearch SL
name: Esther Jiménez Quintana, Ph.D.
role: STUDY_DIRECTOR
References: