Phase 2 Sleep Disorders Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The infant must be healthy, either male or female.
• The infant must be 8 weeks old or younger.
• The infant must have been diagnosed with infantile colic according to specific medical guidelines (called Rome IV criteria), meaning the baby cries or fusses for 3 or more hours per day, on 3 or more days within a 7-day period.
• The infant must be exclusively breastfed and the parent or guardian must plan to continue breastfeeding for the entire duration of the study.
• Both parents or legal guardians must sign a written consent form agreeing to participate.
• Parents or guardians must be willing to fill in questionnaires, keep records and diaries related to the study, and attend all scheduled clinic visits and phone calls.
• At least one parent or legal guardian must be covered by a social security scheme.

Who may not be able to join:

• Infants who weighed less than 2,500 grams (about 5.5 pounds) at birth.
• Infants born before 37 weeks of pregnancy (premature birth).
• Infants who had a low Apgar score (a measure of a newborn's health immediately after birth) of less than 7 at 5 minutes after birth.
• Infants who have been partially or fully fed with formula milk, except during the first 4 days after birth.
• Infants who are not gaining enough weight — specifically gaining less than 100 grams per week since birth.
• Infants with certain digestive conditions, including gastroesophageal reflux disease, short bowel syndrome, chronic intestinal diseases, or physical abnormalities of the digestive system.
• Infants who have or have had a fever, an infectious illness, a current widespread infection, or an infection present from birth.
• Infants with a genetic condition or chromosomal abnormality.
• Infants with a metabolic disease or a condition affecting the pancreas.
• Infants with an immune system disorder.
• Infants with a neurological (brain or nervous system) condition.
• Infants with a known or suspected food allergy or intolerance.
• Mothers who took certain stomach acid–reducing medications (such as proton pump inhibitors or H2 blockers) in the month before giving birth, or who plan to take them during the trial.
• Infants who have taken probiotics, prebiotics, antibiotics, or stomach acid–reducing medications at any point from birth up to the screening appointment, or who would take them during the trial.
• Infants who have been given any anti-colic medication at any point from birth up to the screening appointment.
• Mothers who have taken probiotic or prebiotic supplements between their baby's birth and the screening appointment, or who plan to take them during the trial.
• Infants who are currently enrolled in another clinical trial, or who have taken part in another clinical trial since birth.
• Infants whose parents or legal guardians are unable to sign the consent form due to psychological or language difficulties.
• Infants whose parents or legal guardians cannot be reached in an emergency.

Important: Always verify eligibility with the trial site directly before applying.