None listed
Conditions
Brief summary
Congenital chloride diarrhea (CLD) is an inherited disorder characterized due to mutations in the SLC26A3 gene. The clinical picture of CLD patients range from severe neonatal diarrhea, with high risk of life threatening hypoelectrolytemia and dehydration events, to a relatively mild chronic form. In patients with CLD, oral supplementation therapy with a combination of chloride salts (NaCl and KCl) is essential in preventing episodes of dehydration that could result in mental impairment and renal dysfunctions. Unfortunately, this therapy is unable to limit the severity of diarrhea. Dietary fibres are fermented by intestinal bacteria microflora into short-chain fatty acids (SCFAs), including acetate, propionate, and butyrate. The role of the SCFA has been increasingly recognized for the management of diarrheal diseases. Butyrate is able to exert a powerful pro-absorptive stimulus on intestinal salts. In a child affected by CLD, we demonstrated the therapeutic efficacy of oral butyrate, showing a progressive reduction to normal values in the number of bowel movements and stool volume, an improvement in stool consistency, and a reduction of fecal incontinence episodes. The aim of this study is to evaluated the therapeutic effect of butyrate in children affected by CLD.
Interventions
We used a commercially available sodium butyrate formulation (SOBUTIR, Registered Trademark, Promefarm, Milan, Italy). Butyrate was administered orally at 100 mg/kg/day, divided in 2 doses, with a maximal dosage of 4 g/day, for 1 week. Number of tablets of sodium butyrate (1 gr/tablet) consumed by the child during the trial were reported in a specific form by the parents. A good compliance was considered the intake of at least 80% of the prescribed doses. Parents of the enrolled children were ad
We used a commercially available sodium butyrate formulation (SOBUTIR, Registered Trademark, Promefarm, Milan, Italy). Butyrate was administered orally at 100 mg/kg/day, divided in 2 doses, with a maximal dosage of 4 g/day, for 1 week. Number of tablets of sodium butyrate (1 gr/tablet) consumed by the child during the trial were reported in a specific form by the parents. A good compliance was considered the intake of at least 80% of the prescribed doses. Parents of the enrolled children were advised to avoid co-administration of other treatments, including anti-diarrheal drugs, antibiotics, probiotics or probiotics during the trial. Children continued their normal diet during the study period. During the entire length of the study, all CLD subjects were examined as outpatients and they had free access to the services of referred hospitals.
Sponsors
Department of Pediatrics, University of Naples Federico II
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
All patients (age < 18 years) with diagnosis of congenital chloride diarrhea, will be considered eligible for the study.
Exclusion criteria
Severe clinical conditions, concomitant presence of acute intestinal or extraintestinal infections, probiotics, non-steroideal anti-inflammatory drugs (NSAIDs), or antibiotics use in the last 4 weeks, chronic diseases (inflammatory bowel diseases, congenital motility disorders, food allergy, celiac disease, cystic fibrosis, immunodeficiency).
Outcome results
None listed