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The FA-DIET Study

Efficacy and Tolerability of a Probiotic Supplement Containing Bifidobacterium longum Rosell-175 and Lactobacillus helveticus Rosell-25 (FloraLinkR) in the Management of Symptoms of Anxiety, Depression, and Insomnia among Adult Patients Attending a Family Medicine Clinic in Ilorin, North-central, Nigeria: An Open-Label Randomized Placebo-Controlled Trial (The FA-DIET Study).

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202602553798928
Enrollment
80
Registered
2026-02-20
Start date
2026-02-12
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Mental and Behavioural Disorders

Interventions

FloraLink stick psychobiotic supplement
Placebo

Sponsors

Dr. Obalowu Ismaila Aberi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All consenting adult (male and female) patients between ages 18–65 years 2. Patients diagnosed with at least moderate anxiety using GAD-7 score of =10, and/or diagnosed with depression using QIDS score of =11 during the recruitment. 3. Patients who are on treatments for anxiety disorders or depression in the Family Medicine Clinics already 4. Patients who provide a written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with severe psychiatric illness (e.g., acute psychosis, bipolar disorder, major depression) 2. Use of antibiotics or probiotic supplements within the last 2 weeks 3. Pregnant or lactating women 4. Patients with significant comorbid medical conditions requiring urgent medical attention 5. Concurrent use of any type of laxatives

Design outcomes

Primary

MeasureTime frame
Change in severity of anxiety and depression symptoms from baseline to week 8, as measured by GAD-7 and QIDS-SR tools in both groups.

Secondary

MeasureTime frame
Change in sleep quality

Countries

Nigeria

Contacts

Public ContactAntonia Alabi

Consultant Family Physician

alabi.an@unilorin.edu.ng+2348130718279

Outcome results

None listed

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