Efficacy and tolerability of ABB i5 prebiotic and ABB C22 postbiotics for the management of constipation and gastrointestinal well-being: a pilot trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Postbiotic ABB S3 for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
Oral Rehydration Solution containing postbiotics ABB C22 for the management of diarrhoea signs of dehydration
Placebo for suspension into Nutritional supplementation with Medical Nutrition Formula for the management of gastrointestinal symptoms secondary to enteral nutrition
Isabel Roig
Barcelona, Barcelona, Spain
Faecal calprotectin
change in faecal calprotectin levels (mg/g)
Time frame: from baseline to day 14 of supplementation
faecal lactoferrin
change in the number of participants with a positive "faecal lactoferrin" result (%)
Time frame: from baseline to day 14 of supplementation
Blood IgAs
levels of serum IgAs (mg/dL)
Time frame: from baseline to day 14 of supplementation
Gastrointestinal symptoms
assessment of number of diarrhea, vomits and regurgitation events
Time frame: from baseline to day 14 of supplementation
faecal consisitency
assessed through Bristol scale (1-7 score)
Time frame: from baseline to day 14 of supplementation
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Oral Rehydration Solution containing placebo for the management of diarrhoea signs of dehydration