A practice based trial of a combination of nutritional interventions: probiotics, glutamine and fish oils in patients experiencing psychological distress.

Phase 2

Completed

• Conditions: Mild digestive discomfort; Psychological distress; Alternative and Complementary Medicine - Other alternative and complementary medicine; Mental Health - Other mental health disorders

• Registration Number: ACTRN12620000928910
• Lead Sponsor: Southern Cross University

Brief Summary

Results: The data showed a general trend towards lower K10 scores during the active phase compared with the baseline phase, with a marked reduction in the variances between phases. After controlling for time and baseline values, no significant differences between the phases for the Kessler-10 and the Perceived Stress Scale was found, but there was still a significant reduction in symptoms on the Gastrointestinal Symptom Rating Scale. Conclusions: A combination of a probiotic formulation, a glutamine powder formulation and fish oil did not effect psychological distress and perceived stress, but had a significant beneficial effect on gastrointestinal symptoms in patients with high distress and concurrent gut symptomology.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-17
• Study Completion: 2020-12-31
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Individuals with:
- a score of greater than or equal to 16 and less than 30 on the K-10 scale
- symptoms of mild gut dysfunction (e.g. abdominal cramps or sharp pains, recurrent diarrhoea or constipation, excessive wind, abdominal bloating)
- agree to comply with the study protocols
- willing to have blood taken on two occasions during the study

Exclusion Criteria

Individuals
- taking immunosuppressive medication
- taking Warfarin or other anticoagulant medication
- who have major surgery within the last 6 months
- diagnosed with chronic mental health conditions and taking prescribed medication for same (unless their condition has been stable for a minimum of 12 months)
- with diabetes
- with BMI greater than or equal to 35
- unexplained weight loss
- Females who are lactating, pregnant or planning to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kessler-10 scale of psychological distress (K-10); a 10 item validated and reliable scale of the risk of severe mental disorder. <br>Change in total score as estimate of change in risk of mental disorder. [Seven time points; the initial screening clinic (week -2) and 6 subsequent clinics (week 0, week 4, week 8, week 12, week 16 and week 18).]