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New treatment option for Infantile Colic
Official title Effect of Probiotics on Infantile Colic Symptoms
ClinicalTrials.gov ID: NCT06385054
What this study is testing
- What it's testing
- The aim of this clinical trial is to assess the impact of B. lactis B94 on participants with infantile colic.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 8
You may be able to join if
- I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss...
- I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
- I5. With a written informed consent signed by the father and mother or legal guardian.
- I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled...
- I7. At least one of the legal representatives is affiliated with a social security scheme.
You likely can't join if
- E1. Birthweight \< 2500 g. E2. Gestational age \< 37 weeks. E3. Apgar score at 5 minutes \< 7. E4. Partially or fully formula fed infants except for...
- E5. Stunted growth/weight loss (\< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic...
- E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological...
- E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and...
- E15. Use of anti-colic medication at any time from birth to the moment of screening.
See the full eligibility criteria
- I1. Healthy male or female. I2. Age ≤ 8 weeks old. I3. Diagnosis of infantile colic according to the Rome IV criteria. Infants must show cry or fuss behavior for 3 or more hours per day, during 3 or more days in 7 days.
- I4. Exclusively breastfeeding and planning to breastfeed for the duration of the study.
- I5. With a written informed consent signed by the father and mother or legal guardian.
- I6. With parents willing to complete questionnaires, records, and diaries associated to the study and to complete all clinical visits and scheduled telephone calls.
- I7. At least one of the legal representatives is affiliated with a social security scheme.
- E1. Birthweight \< 2500 g. E2. Gestational age \< 37 weeks. E3. Apgar score at 5 minutes \< 7. E4. Partially or fully formula fed infants except for the 4 first days after birth.
- E5. Stunted growth/weight loss (\< 100 g/week from birth to last reported). E6. Gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or gastrointestinal malformations.
- E7. Diagnosed or reported fever and/or infectious diseases, or current systemic infections, or history of congenital infections.
- E8. Genetic diseases and chromosomal abnormalities. E9. Metabolic diseases or pancreatic insufficiency. E10. Immunodeficiency. E11. Neurological diseases. E12. Suspected or confirmed food allergies and intolerances...
- E14. Use of probiotics, prebiotics, antibiotics, or gastric acid inhibitors by the infant at any time from birth to the moment of screening and during the trial.
- E15. Use of anti-colic medication at any time from birth to the moment of screening.
- E16. Use of probiotics and prebiotics supplements by the mother between the birth of their infant and the moment of screening and intend to consume any during the trial.
- E17. Currently enrolled in another clinical study or having participated in another clinical from birth to the moment of screening.
- E18. Whose legal representatives have psychological or linguistic incapability to sign the informed consent.
- E19. Impossibility to contact the legal representatives in case of emergency.
The study team makes the final eligibility decision.
Where it's taking place
- Bécon-les-Granits, France
- Boulogne-sur-Mer, France
- Caen, France
- La Tronche, France
- Lille, France
- Montauban, France
- Nantes, France
- Paris, France
- Saint-Herblain, France
- Saint-Jean-de-Verges, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 8 weeks. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bécon-les-Granits, France; Boulogne-sur-Mer, France; Caen, France; La Tronche, France; Lille, France; Montauban, France and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.