Probiotics for Depressive Symptomatology and Neural Activity.

NCT07667530 | Not Yet Recruiting

• 1 other identifier: UReading Probiotics Depression
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the acute and chronic effects of 16-week probiotic supplementation (Ecologic® Barrier) on depressive symptoms and neural activity in those with mild-to-moderate depression.

Conditions

Mild-to-moderate Depression; Neural Activity; Executive Function (Cognition)

Keywords

Mild-to-moderate Depression; Probiotic Supplementation; Neural Activation; Executive Function

Outcome Measures

Primary Outcomes (1)

• Leiden Index of Depression Sensitivity - Revised (LEIDS-R) vulnerability/sensitivity for depression.

  A standardised measure of cognitive reactivity. This questionnaire consists of 34 items, in which participants rate on a scale from 0 to 4, how strongly they feel each statement relates to them when they feel somewhat sad.

  Baseline and 16 weeks

Secondary Outcomes (11)

• Leiden Index of Depression Sensitivity - Revised (LEIDS-R). The following subscales are of interest: rumination, hopelessness/suicidality, acceptance/coping, aggression, control, and risk aversion.

  Baseline, 24 hours, and 16 weeks

• Beck Depression Inventory (BDI-II)

  Screening, baseline, 24 hours, and 16 weeks

• Mini-International Neuropsychiatric Interview (MINI)

  Baseline, 24 hours, and 16 weeks

• Rumination Response Scale (RRS)

  Baseline, 24 hours, and 16 weeks

• Neural Activity

  baseline, 24 hours, and 16 weeks

Other Outcomes (3)

• Generalised Anxiety Disorder-7 (GAD-7)

  Baseline

• Menstrual Cycle Data

  Baseline and 16 weeks

• Epic-Norfolk Food Frequency Questionnaire (FFQ)

  Baseline and 16 weeks

Study Arms (2)

Ecologic® Barrier

EXPERIMENTAL

Participants will consume one sachet of Ecologic® Barrier powder(1x10\^10 CFU/day), mixed in warm water with a meal. The sachets can be stored at room temperature.

Dietary Supplement: Ecologic® Barrier

Placebo powder

PLACEBO COMPARATOR

A placebo matched for packaging, visual appearance, smell, and taste will be given. Similar to the instructions on how to take the probiotic, subjects will consume one sachet per day, kept at room temperature, mixed into warm water with a meal.

Dietary Supplement: Placebo powder

Interventions

Ecologic® Barrier DIETARY_SUPPLEMENT

Ecologic® Barrier (1x1010 CFU/day).

Also known as: Probiotics

Ecologic® Barrier

Placebo powder DIETARY_SUPPLEMENT

Matched placebo

Also known as: placebo

Placebo powder

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Mild to moderate depression symptoms (BDI-II 12-28)
• Males and females
• Age range will be 25-40 years
• Right-handed participants only (required for EEG)

You may not qualify if:

• Any diagnosed chronic medical condition (e.g. diabetes) or psychiatric illness.
• Following restrictive and/or unbalanced diets
• Smoking
• Continuous use of a weight-loss medication for more than one month prior to screening
• Significant gastrointestinal conditions affecting absorption, including but not limited to: inflammatory bowel disease; total colectomy or bariatric surgery; irritable bowel disease; end-stage renal disease; active cancer or cancer treatment within the past three years

Sponsors & Collaborators

• University of Reading: lead
• Winclove Probiotics B.V.: collaborator

Study Sites (1)

School of Psychology and Clinical Languages

London, RG6 6UR, United Kingdom

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Double-blind, placebo-controlled, randomised control trial.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: June 25, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)