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

Not Applicable

• Conditions: Healthy individuals experiencing mild to moderate gastrointestinal symptoms; Digestive System

• Registration Number: ISRCTN17696788
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-17
• Last Update Posted: 22 July 2024
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 146

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1.Gut Transit Time measured using the blue dye method at week 0 and week 8<br>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<br>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<br>4.Faecal Calprotectin levels measured using stool samples provided by participants which will be analysed in an external lab at weeks -4, 4 & 12<br>5.Flatulence measured using a tally counter (day time anal gas evacuation) on the previous week before each study visit. <br><br>