Effect of a novel prebiotic in adults with mild constipatio

Not Applicable

Completed

• Conditions: Constipation; Gastrointestinal health; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12620001247965
• Lead Sponsor: Integria Healthcare (Australia) Pty Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-20
• Study Completion: 2021-01-29
• Last Update Posted: 26 October 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in stool output frequency, measured as complete spontaneous bowel motions (CSBM)[From baseline to 3 weeks post intervention commencement, assessed weekly through structured interview at days 7, 14 and 21. ]