Gut Bugs Trial - Gut microbiome transfer for the treatment of adolescent obesity

Not Applicable

Completed

• Conditions: Obesity (BMI more or equal to 30 kg/m2); Diet and Nutrition - Obesity; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12615001351505
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-14
• Study Completion: 2019-03-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

Recipient subjects (40 males and 40 females):
• Age 14-18 years
• Obese (BMI: greater or equal than 30 kg/m2)
• Post-pubertal (Tanner stage 5)

Gut microbiome donors:
• Age 18-28 years
• BMI greater than 18.5 kg/m2 and less than 30.0 kg/m2
• Total body fat percentage: less than or equal to 29% for females; less than or equal to 19% for males
• Regular exercise (moderate to vigorous physical activity for at least 3.5 hours/week)
• Regular Bowel Habit (at least 1 every 2 days)
• Intake greater than or equal to 4 portions of fruit and/or vegetables per day

Exclusion Criteria

Donors:
• Any transmissible viral or bacterial pathogens, or intestinal parasites
• Multidrug-resistant organisms (e.g. vancomycin-resistant enterococci, extended-spectrum beta-lactamase-producing Enterobacteriaceae, and carbapenem-resistant Enterobacteriaceae)
• Gastrointestinal disease (including symptoms of irritable bowel syndrome, inflammatory bowel disease, or coeliac disease)
• Atopic diseases requiring regular prophylaxis or treatment
• Current or past history of malignancy
• Impaired fasting glucose or impaired glucose tolerance
• Type 1 diabetes, type 2 diabetes, or monogenic diabetes
• Known dyslipidaemia, hypertension, or metabolic syndrome
• Regular use of medications known to influence metabolism or the gut microbiome
• Use of oral antibiotics in the past three months
• Regular 'binge drinking', i.e. consumption of 5 or more standard drinks of alcohol per session, at least once a week
• Any use of recreational drugs or tobacco
• Current or past pregnancy
• Overseas travel in previous 6 months, except for visits to Australia, UK, USA, Canada, Northern Europe, France, and Germany.
• UK residence in 1980–1996 (due to risk of variant Creutzfeldt-Jakob disease)

Recipients:
•Gastrointestinal disease (including inflammatory bowel disease or coeliac disease)
•Use of regular medications that may influence weight, metabolism, or the gut microbiome (including oral oestrogen-containing contraceptives, antidepressants, glucose-lowering drugs, diet drugs, as well as inhaled, topical, or oral steroids)
•Consumption of probiotics
•Type 1 diabetes, type 2 diabetes, or monogenic diabetes
•Chronic diseases that could affect the primary outcome (other than obesity-related conditions)
•Food allergies
•Allergy to macrogol (active ingredient in the bowel preparation product)
•Allergy to any over-the-counter medication
•No antibiotic usage for three months prior to trial treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified