Effect of a novel prebiotic in adults with mild constipation

A randomised, single-blinded, controlled trial of a novel prebiotic formulation; assessing changes in stool frequency in adults with mild constipation

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001247965

Enrollment

Registered

2020-11-20

Start date

2020-11-02

Completion date

2021-01-07

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

A novel prebiotic product, targeted for microbiome modulation in patients with low levels of fibre intake and those prone to constipation.

Interventions

Prebiotic multi-ingredient formulation: A novel prebiotic powder containing partially hydrolysed guar gum, red dragon fruit extract, acacia gum, slippery elm, cacao extract and pectin. Dose - 6 g twice daily (total of 12 g/day) mixed with 150 mL of water Duration - 3 weeks Mode of administration - oral, powder Intervention compliance will be assessed by measurement of weight of returned product.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

25 Years to 45 Years

Healthy volunteers

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

Outcome results