View clinical trials related to Infantile Colic.
Filter by:The aim of this clinical trial is to assess the impact of a probiotic formulation on participants with infantile colic. It is hypothesized that participants given the probiotic formula will have a significant reduction in their crying duration compared to participants receiving the placebo, after 4 weeks of intervention.
Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks. Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening. Infantile Colic is a non-pathological condition that causes babies to cry excessively throughout their first few months of life. It has a prevalence of 15-30% and is defined by excessive sobbing for at least 3 hours per day, 3 days per week for around 3 weeks. Excessive sobbing, blushing, parachroma around the lips, bloating in the abdomen, drawing the legs into the abdomen, coldness at the ends, and fisting of the hands are all symptoms of infantile colic. Another significant clinical aspect of Infantile Colic is its protracted, difficult to soothe, and inexplicable nature. Infantile Colic is thought to have a cicadian pain cycle that begins in the evening. Anxiety and stress that arise during the postpartum period cause a variety of issues in both the mother and the baby, and have a negative impact on the mother-baby bond as well as the mother's care and parenting skills. Sleep deprivation, sleep disturbance, and exhaustion are said to be caused by the sensation of not being able to meet the child's demands. It has been found that as parental stress levels rise, the gut flora deteriorates, and increasing cortisol in breast milk increases the baby's crying attacks. Colic and excessive crying are also risk factors for unfavorable parent-infant interactions. Infantile Colic has been shown to have a negative impact on children's health in the short and long term for all of these reasons. As a result, healthcare experts must devise therapies to lessen the painful impact of Infantile Colic on babies and their families. As a result, the purpose of this study was to see how supportive care training for parents affected the colic levels of babies with Infantile Colic, as well as mothers' perceptions of nursing and parental self-efficacy.
This study evaluates the efficacy of single strain probiotic administered in a form of a sachet in the treatment of infant colic in infants 3-12 weeks old.
Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby on crying behavior and fecal calprotectin levels in babies diagnosed for infantile colic.
Study type: Randomized controlled trial with two parallel arms Objectives Primary : Demonstrate that daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 decreases the daily crying duration at 21 days Secondary : Evaluate the effects of daily supplementation of colicky infants with Nidina formula containing L. reuteri DSM 17938 measured as 1. the number of "responders" or the "treatment success" (ie infants for which defined as the percentage of children achieving a reduction in the daily average crying time >50% in 3 weeks. (day 1 to day 21 of the study) 2. maternal depression and family functioning scoring
This study will work on hypothetical assumption that compared to the arm supplemented with placebo (control) group; the L reuteri (intervention) group will lower daily crying/fussing time per 24 hours at one month post randomization. And that the L reuteri (intervention) group at 7, 14, 21, days and 1 week after the therapy cessation will have: - Lower crying/fussing time per 24 hours. - Relief from colic pain - Longer sleep duration, - Higher scores on a standardized measure of maternal mental health