Dettagli per singolo studio

DEC-NET Serial number IT523

Published online	05/12/2005 15.32.00
Last updated	05/12/2005 15.31.49

Other protocol ID number	19153/283
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Abdominal pain
Experimental drug
Lactobacillus Reuteri ATCC 55730 Treatment regimen (dosage and duration) 5 drops once a day (108 CFU), 30 min after feeding time for 28 days
Control drug
Simeticone Treatment regimen (dosage and duration) 15 drops twice a day (60 mg/day) after feeding time for 28 days
Gender	Both
Age (range)	21 - 90 days
Eligibility criteria
Inclusion criteria
- Infants with diagnosis of infantile colic, according to Wessel.s criteria; - Adequate for gestational age with a birth weight between 2500 and 4000g; - Exclusively breast-fed
Exclusion criteria
Infants are excluded if they have clinical evidence of chronic illness or gastrointestinal disorders and if they have received antibiotics and probiotics in the week preceding recruitment.
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised
Purpose of study
To reduce the crying time related to infantile colic by .modulating. the gut microflora of colicky infants by the oral administration of probiotics.
Primary outcomes
For the evaluation of the efficacy on infantile colic, the primary outcome of this study is the reduction of the daily average crying time between baseline to the end of the treatment period.
Secondary outcomes
Secondary outcome consists of the number of responders versus non-responders in each group at the end of the treatment. Patients are classified as responders if they experience a decrease in the daily average crying time of 50% from baseline to the end of treatment.
Summary of study design, objectives, and ongoing research findings
Infantile colic, also known as evening colic, is one of the most common problems within the first three months of life, affecting as many as 3% to 28% of newborn children. Its aetiology still remains unclear: recently, among organic theories, a role played by the intestinal microflora has been suggested in the etiopathogenesis of infantile colic and a lower count of intestinal lactobacilli has been observed in colicky infants in comparison to healthy infants. Lactobacillus reuteri, one of the few indigenous Lactobacillus species in the human gastrointestinal tract, has been used safely for many years as a probiotic dietary supplement in adults and, recently, also in newborn infants. Its positive effects on intestinal disorders such as diarrhoea, constipation and protection from infection as well as its capacity to modulate immune responses have been also demonstrated. A minor microbial stimulation during the first months of life modifies immune responses and avoids the development of tolerance to ubiquitous allergens. The intestinal microflora may play a particular role in this respect, as it is the major external driving force in the maturation of the immune system after birth. We hypothesized that .modulating. the gut microflora of colicky infants by the oral administration of probiotics would decrease the crying time related to infantile colic. Preliminary results At Dicember 2005 90 infants were enrolled in our Department and of these patients 7 were excluded from the study (4 from the L. reuteri group and 3 from the Simethicone group). 83 infants completed the trial: 41 in the treatment group and 42 in the control group. The 2 groups are similar regarding age, birth weight, gender, type of delivery, family history of atopy or gastrointestinal diseases, and exposure to smoking (P > .05). The average crying time per day is similar in the two treatment groups at day 0, before starting treatment (205.6 ą 25.6 min/day in the P group and 204.5 ą 25.0 min/day in the S group, P = .835) and at day 1 (190.7 ą 33.8 min/day in the P group and 194.1 ą 35.5 min/day in the S group P = .661). Infants receiving L. reuteri showed a significant reduction in daily crying time at day 7 (146.8 ą 41.2 min/day) compared to infants treated with Simethicone (171.6 ą 40.2 min/day) (P = .007). On day 14, 21 and 28 crying episodes were significantly different between the two treatment groups (P < .001). At day 28, 39 patients (95%) in the P group and 3 patients (7%) in the S group responded to treatment with a decreased daily average crying time of 50% from baseline. Our data were also analysed with respect to family history of atopy and severity of infantile colic. Among patients with a family history of atopy (N = 39), infants receiving Lactobacillus reuteri (N = 17) showed daily crying time significantly reduced compared to infants receiving Simethicone (N = 22) at day 14, 21 and 28. No side effects were observed in either group.