Can taking probiotics improve well-being in females suffering from irritable bowel syndrome?

The impact of probiotics on well-being during irritable bowel syndrome: a double-blind, randomised, placebo-controlled, feasibility study in female participants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14866272

Enrollment

Registered

2022-07-20

Start date

2022-07-25

Completion date

Unknown

Last updated

2024-02-19

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

Conditions

Irritable bowel syndrome (IBS) Digestive System Irritable bowel syndrome

Interventions

Trial subjects are allocated in a 1:1 ratio into two parallel study arms (active arm or placebo arm) according to a randomisation protocol provided by an independent statistician. The intervention com

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Females aged 18 to 40 years 2. Diagnosed IBS (according to the Rome IV criteria) 3. Willing to provide faecal/blood samples 4. Not suffering from any other gastrointestinal disorders/conditions or had abdominal surgery 5. Willing to maintain a normal diet and lifestyle throughout the study 6. Normal (or corrected-to-normal) vision without colour blindness in order to complete the cognitive task

Exclusion criteria

Exclusion criteria: 1. Consumed regular probiotic supplementation within the last 1 month prior to the study 2. Consumed any oral antibiotic within the last 3 months 3. Diagnosed with diabetes 4. Are immunodeficient or undergoing immunosuppressive therapy 5. Diagnosed with arrhythmia, ventricular extrasystole or atrioventricular block 6. Diagnosed with a cardiovascular disease 7. Pregnancy or planning pregnancy 8. Diagnosed with a severe systemic disease e.g. cancer, dementia, advanced organ failure 9. Unexplained loss of weight in recent months

Design outcomes

Primary

Measure	Time frame
Irritable bowel syndrome severity measured by the IBS-symptom severity score (IBS-SSS) questionnaire on days 0, 14, 28, 42 and 56	—

Secondary

Measure	Time frame
1. Bowel habits measured by bowel habit diaries (BHDs) completed by the participants on a per defecation basis during the intervention period 2. Quality of life measured by quality of life questionnaire [QOLQ], IBS Behavioural-responses questionnaire [IBS-BRQ] and the Hospital Anxiety and Depression Scale [HADS] questionnaires on days 0 and 56 3. Cognitive health measured by the word-colour Stroop test on days 0 and 56 4. The faecal microbiota measured by next-generation 16s sequence analysis and culturomics of stool samples taken on days 0 and 56 5. Circulating biomarkers of IBS measured by ELISA analysis of plasma samples taken on days 0 and 56	—

Measure

Time frame

1. Bowel habits measured by bowel habit diaries (BHDs) completed by the participants on a per defecation basis during the intervention period 2. Quality of life measured by quality of life questionnaire [QOLQ], IBS Behavioural-responses questionnaire [IBS-BRQ] and the Hospital Anxiety and Depression Scale [HADS] questionnaires on days 0 and 56 3. Cognitive health measured by the word-colour Stroop test on days 0 and 56 4. The faecal microbiota measured by next-generation 16s sequence analysis and culturomics of stool samples taken on days 0 and 56 5. Circulating biomarkers of IBS measured by ELISA analysis of plasma samples taken on days 0 and 56

—

Countries

Bulgaria

Outcome results

None listed

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