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Evaluation of the response of different types of gut microbiota populations to prebiotics

Evaluation of the response of different types of gut microbiota populations to prebiotics

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073457
Enrollment
Unknown
Registered
2023-07-11
Start date
2023-07-15
Completion date
Unknown
Last updated
2023-07-16

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

Conditions

None

Interventions

Oligofructose intervention in the high group:Oligofructose intervention for 14 days
Oligofructose intervention in the low group:Oligofructose intervention for 14 days
Inulin intervention in the high group:Inulin intervention for 14 days
Inulin intervention in the low group:Inulin intervention for 14 days

Sponsors

School of Food Science and Technology, Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Healthy men and women aged 18 to 70 years, with a male to female ratio of 1:1; (2) Not currently following any dietary programme or dietitian consultation; (3) BMI: 18.5 to 24.9 kg/m2; (4) Compliance with relevant regulations during the clinical trial, good adherence and ability to deliver samples on time; (5) The volunteer or guardian has signed the informed consent form (Schedule 1); (6) Volunteers completed the basic information questionnaire (Schedule 2), the dietary structure and living conditions questionnaire (Schedule 3), and the gastrointestinal symptoms rating scale (Schedule 4), and undertook to cooperate with the study throughout the experimental period.

Exclusion criteria

Exclusion criteria: (1) Suffering from gastrointestinal, neurological, cardiovascular, endocrine, renal or other chronic diseases that may affect the dynamics of the bowel; (2) Having undergone major abdominal surgery, especially of the gastrointestinal tract; (3) Use of medication related to gastrointestinal conditions such as anti-spasmodics, laxatives, anti-diarrhoeal drugs and other drugs that have an effect on intestinal motility within two weeks; (4) Women during pregnancy or lactation; (5) Allergy or lactose intolerance to the ingredients of the experimental probiotic product; (6) Consumption of yoghurt, probiotics, prebiotics, synbiotics, dietary supplements, herbs, or high doses of vitamins or minerals within 1 month or for a prolonged period of time; (7) Use of antibiotics within 1 month or for a long period of time, glucocorticoids, immunosuppressive drugs within 3 months or for a long period of time; (8) Significant change in dietary habits within 1 month, such as starting a fibre-rich diet (>18 g/day) (9) Hospital diagnosis of chronic illness, immune system disorders, mental illness, infectious diseases or major diseases; (10) Alcohol or substance abuse; (11) Undergoing other clinical studies within 1 month (12) Refusal to sign the informed consent form or poor estimated compliance and poor likelihood of follow-up.

Design outcomes

Primary

MeasureTime frame
gut microbiota;Gastrointestinal Symptom Rating Scale,GSRS;

Secondary

MeasureTime frame
Short-chain fatty acid;Fecal metabolome;

Countries

China

Contacts

Public ContactQixiao Zhai

School of Food Science and Technology, Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 159 6176 0920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026