The effect of fermented milk powder on gut health in healthy individuals with mild to moderate symptoms

Fermented milk powder to aid gut health and quality of life in healthy inidividuals with mild to moderate gastrointestinal symptoms compared with placebo, and non-fermented milk control

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17696788

Enrollment

120

Registered

2023-10-17

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-08-24

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

Conditions

Healthy individuals experiencing mild to moderate gastrointestinal symptoms Digestive System

Interventions

A total of n=120 participants (total across both sites) will be recruited to this single-blinded study with a parallel design that will involve a 4-week baseline phase before participants are randomis

Eligibility

Sex/Gender

All

Age

20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Respondents aged 20-45 years old. 2. Respondents who have self-reported mild to moderate digestive issues as per the Structured Assessment of Gastrointestinal Symptoms (Koloski et. al) / Hospital Anxiety and Depression Scale (Zigmond et. al, 1983) questionnaires.

Exclusion criteria

Exclusion criteria: 1. Respondents who report lactose intolerance 2. Respondents who report either very mild or very severe gastrointestinal issues. 3. Post-menopausal women or those experiencing menopause. 4. Respondents who report self-medication with probiotics or similar products for gastrointestinal issues will be excluded or will have to undergo a washout period before recruitment. 5. Respondents who report medical issues that affect gut transit/digestion. 6. Respondents who report living situations where they are not independently living, or require care. 7. Respondents who report regular taking antacids. 8. Respondents who report that they are smokers. 9. Respondents who report they are pregnant or lactating. 10. Respondents who have been prescribed antibiotics in the last 3 months. 11. Respondents who report having Type-1 Diabetes.

Design outcomes

Primary

Measure	Time frame
The Functional Digestive Disorders Quality-of-Life questionnaire (FDDQoL) measured once per week each week for 16 weeks	—

Secondary

Measure	Time frame
1. Gut Transit Time measured using the blue dye method at week 0 and week 8 2. Constipation measured using The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) & Bristol Stool Chart at weeks -4, 0, 4, 8 & 12 3. Microbial diversity measured using stool samples provided by participants which will be analysed in an external lab at weeks -4, 0, 4, 8 & 12 4. Faecal Calprotectin levels measured using stool samples provided by participants which will be analysed in an external lab at weeks -4, 4 & 12 5. Flatulence measured using a tally counter (day time anal gas evacuation) on the previous week before each study visit.	—

Measure

Time frame

1. Gut Transit Time measured using the blue dye method at week 0 and week 8 2. Constipation measured using The Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) & Bristol Stool Chart at weeks -4, 0, 4, 8 & 12 3. Microbial diversity measured using stool samples provided by participants which will be analysed in an external lab at weeks -4, 0, 4, 8 & 12 4. Faecal Calprotectin levels measured using stool samples provided by participants which will be analysed in an external lab at weeks -4, 4 & 12 5. Flatulence measured using a tally counter (day time anal gas evacuation) on the previous week before each study visit.

—

Countries

Ireland

Contacts

Public ContactAlice Lucey

a.lucey@ucc.ie+353 86 3285776

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Sep 19, 2026