NCT04616937

Brief Summary

A behavioural study of the microbiota-gut-brain axis in brain development and mental health

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

October 28, 2020

Last Update Submit

November 3, 2020

Conditions

Emotion RegulationAnxiety

Outcome Measures

Primary Outcomes (8)

  • Behavioural indices of emotion regulation

    Changes in performance on dot-probe task measured as attentional bias to emotional stimuli in milliseconds in the prebiotic group compared to placebo. Increased attentional bias to positive stimuli and/or decreased attentional bias to negative stimuli is the desired outcome.

    4 weeks

  • Changes in self reported indices of anxiety.

    Changes in self reported anxiety as measured by the Trait Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.

    4 weeks

  • Changes in self reported indices of anxiety 2.

    Changes in self reported anxiety as measured by the State Anxiety subscale of the State-Trait Anxiety Inventory (Spielberger, 1978) in the prebiotic group compared to placebo group. For this inventory, a lower overall score is the desired outcome.

    4 weeks

  • Changes in self reported indices of anxiety 3.

    Changes in self reported social anxiety measured by Social Anxiety Scales (La G reca 1999) in the prebiotic group compared to placebo group. For this scale, a lower overall score is the desired outcome.

    4 weeks

  • Changes in self reported emotion regulation (Thought control ability).

    Changes in the prebiotic group compared to placebo for Thought control ability (Luciano et al 2005). For this questionnaire, a higher overall score is the desired outcome.

    4 weeks

  • Changes in self reported emotion regulation (Emotion regulation strategies).

    Changes in the prebiotic group compared to placebo for emotion regulation strategies (Gross \& John, 2003). For this questionnaire, a higher overall score is the desired outcome.

    4 weeks

  • Changes in self reported mood

    Changes in the prebiotic group compared to placebo for mood and feelings as measured by the mood and feelings questionnaire (Angold etal., 1995). A lower overall score is the desired outcome.

    4 weeks

  • Changes in self reported depression.

    Changes in the prebiotic group compared to placebo for depression as measured by the Depression inventory (Beck \& Steer, 1984). A lower score is the desired outcome.

    4 weeks

Secondary Outcomes (1)

  • Gut microbiota changes

    4 weeks

Other Outcomes (1)

  • Exploratory: Changes in nutrient intake and food choice

    4 weeks

Study Arms (2)

Galacto-oligosaccharides (GOS) Group

ACTIVE COMPARATOR

Daily dose of GOS over 4 weeks

Dietary Supplement: GOS

Placebo group

PLACEBO COMPARATOR

Daily dose of maltodextrin over 4 weeks

Dietary Supplement: Placebo

Interventions

GOSDIETARY_SUPPLEMENT

Prebiotic

Galacto-oligosaccharides (GOS) Group
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Females
  • Aged between 18-25

You may not qualify if:

  • Clinical levels of anxiety and/ or co-morbid diagnoses (e.g. depression)
  • Current or previous neurological disorders
  • Current or previous psychiatric disorders
  • Current or previous gastrointestinal disorders
  • Current or previous endocrine disorders
  • Antibiotic use 3 months prior to the study
  • Regular use of pre- and probiotics, including 3 months prior to the study
  • Vegan diets
  • BMI \>30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

Location

MeSH Terms

Conditions

Emotional RegulationAnxiety Disorders

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 28, 2020

First Posted

November 5, 2020

Study Start

February 1, 2018

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

November 5, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)