ACTRN12620001247965
Completed
未知
A randomised, single-blinded, controlled trial of a novel prebiotic formulation; assessing changes in stool frequency in adults with mild constipation
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Constipation
- Sponsor
- Integria Healthcare (Australia) Pty Ltd.
- Enrollment
- 61
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants meeting with following criteria to be included in the study:
- •\- Male and females aged 25 to 45 years.
- •\- Participants who can provide informed consent.
- •\- Consumption of less than 4 serves of vegetables, fruit and wholegrains combined per day on average.
- •\- 1\-4 stools/week on average (complete spontaneous bowel motion).
- •\- BMI \< 18\.5 \< 35\.
Exclusion Criteria
- •Participants meeting with following criteria to be excluded from the study:
- •\- Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put participant at risk of adverse events including: Physical examination; Clinical chemistry; Haematology; Vital signs
- •\- History of diagnosis of gastrointestinal disease, inflammatory bowel disease, or functional
- •gastrointestinal disorders, previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery) or experiencing dysphagia
- •\- Systemic lupus erythematosus, cancer, thyroid disease, renal disease, hepatic disease, or uncontrolled metabolic disease
- •\- Individuals taking probiotics, antibiotics, fibre supplements, antacids, proton pump inhibitors, stool softeners or laxatives at time of recruitment or within the previous four weeks
- •\- Has any allergies or past reactions to ingredients in treatment and placebo, including acacia gum, guar gum or maltodextrin
- •\- Women only) Pregnancy or nursing of an infant
Outcomes
Primary Outcomes
Not specified
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