Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Exploratory Study to Evaluate the Effect of L-isoleucine Supplemented Oral Rehydration Solution in the Treatment of Acute Diarrhoea in Children and in Inducing Innate Immunity
Brief Summary: Efforts are continuing to improve the efficacy of oral rehydration solution in terms of reducing the severity (stool volume) and duration of diarrhoea (enhancement of recovery). Antimicrobial peptides, produced by the epithelial cells, represent an important component of the innate immunity of all epithelial surfaces of the body including intestine. Induction of expression of antimicrobial peptides on epithelial cell surface, may thus hasten recovery from infectious diarrhoea. Isoleucine is an essential amino acid that is easily available and not very expensive, and its addition to oral rehydration solution might help early clearance of diarrhoeal pathogen by inducing secretion of antimicrobial peptide by the small intestinal epithelial cells. Additionally, it is expected to hasten recovery from diarrhoea by reestablishing the commensal bacteria. The aim of this pilot study is to assess if addition of isoleucine to oral rehydration solution induces secretion of antimicrobial peptide, help establish normal bacterial populations in the intestine, and favourably impacts the severity and duration of diarrhoea in young children. If the results are found encouraging, a therapeutic trial with adequate sample size would be justified.


Options:
A: Arm Label: Arm 1 - AA Formula with DHA and ARA; Type: OTHER; Interventions: Other: Amino Acid-based Formula with high DHA and ARA | Arm Label: Arm 2 - AA Formula with alternative levels of DHA and ARA; Type: OTHER; Interventions: Other: Amino Acid-based Formula with lower DHA and ARA | Intervention Type: OTHER; Name: Amino Acid-based Formula with high DHA and ARA; Assigned to Arm(s): Arm 1 - AA Formula with DHA and ARA | Intervention Type: OTHER; Name: Amino Acid-based Formula with lower DHA and ARA; Assigned to Arm(s): Arm 2 - AA Formula with alternative levels of DHA and ARA
B: Arm Label: New Thickened Amino acid based formula; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Amino acid based formula | Arm Label: Amino acid based formula; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Amino acid based formula | Intervention Type: DIETARY_SUPPLEMENT; Name: Amino acid based formula; Assigned to Arm(s): Amino acid based formula, New Thickened Amino acid based formula
C: Arm Label: Isoleucine; Type: ACTIVE_COMPARATOR; Interventions: Other: ORS + Isoleucine | Arm Label: ORS without Isoleucine; Type: PLACEBO_COMPARATOR; Interventions: Other: ORS without Isoleucine | Intervention Type: OTHER; Name: ORS + Isoleucine; Assigned to Arm(s): Isoleucine | Intervention Type: OTHER; Name: ORS without Isoleucine; Assigned to Arm(s): ORS without Isoleucine
D: Arm Label: New Amino Acid formula; Type: EXPERIMENTAL; Interventions: Other: Amino Acid formula | Arm Label: Control formula; Type: ACTIVE_COMPARATOR; Interventions: Other: Commercially available Amino Acid Formula | Intervention Type: OTHER; Name: Amino Acid formula; Assigned to Arm(s): New Amino Acid formula | Intervention Type: OTHER; Name: Commercially available Amino Acid Formula; Assigned to Arm(s): Control formula

Answer: C