Colic
Conditions
Keywords
Infantile colic, Crying time, Probiotics, Sleep duration
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.
Interventions
DIETARY_SUPPLEMENTProbiotic 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
ProbiSearch SL
Lallemand Health Solutions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
No minimum to 8 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of infantile colic | 5 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time | 5 weeks | 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: Daily crying duration | 5 weeks | 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 | 5 weeks | 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 | 5 weeks | 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: Parental perception | 5 weeks | 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. |
| Fecal strain recovery of the probiotic | 5 weeks | 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 | 5 weeks | 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. |
| Change in the mother's quality of life | 5 weeks | 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 | 5 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fecal protein markers | 5 weeks | 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. |
| Incidence of Adverse Events | 6 weeks | Comparison of the number of adverse events (AEs) and serious adverse events (SAEs) recorded in the probiotic and placebo groups. |
Countries
Spain
Outcome results
None listed