The Role of the Microbiota-gut-brain Axis in Brain Development and Mental Health

NCT03835468 | Unknown

• 1 other identifier: PrebioticExtensionStudyGU2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The role of the microbiota-gut-brain axis in brain development and mental health

Conditions

Gamma-Aminobutyric Acid; Anxiety; Glutamate; Emotion Regulation Abilities

Outcome Measures

Primary Outcomes (7)

• Changes in brain indices of emotion regulation abilities as a function of prebiotic intake 1

  Increase in brain-based metabolite concentrations (gamma-aminobutyric acid (GABA)) as assessed via Magnetic resonance spectroscopy in the prebiotics group in comparison to the placebo group.

  4 weeks of intervention

• Changes in brain indices of emotion regulation abilities as a function of prebiotic intake 2

  Increase in functional connectivity in brain networks supporting emotion regulation abilities (as assessed via functional magnetic resonance imaging) in the prebiotics group in comparison to the placebo group.

  4 weeks of intervention

• Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 1

  Decrease in Trait anxiety (State-Trait Anxiety Inventory, Spielberger, 1977) in the prebiotics group in comparison to the placebo group.. For this inventory, a lower overall score is the desired outcome.

  4 weeks of intervention

• Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 2

  Decrease in Social Anxiety for adolescents (Social Anxiety Scales, La Greca, 1999) in the prebiotics group in comparison to the placebo group. For this scale, a lower overall score is the desired outcome.

  4 weeks of intervention

• Changes in psychological measures of emotion regulation abilities as a function of prebiotic intake 3

  Increase in thought control ability (Thought control ability questionnaire, Luciano et al., 2005) in the prebiotics group in comparison to the placebo group.. For this questionnaire, a higher overall score is the desired outcome.

  4 weeks of intervention

• Changes in gut microbiome composition as a function of prebiotic intake

  Increase in beneficial gut bacteria (percentage) in the prebiotics group in comparison to the placebo group. Based on stool sample analyses and microbiome sequencing.

  4 weeks of intervention

• Changes in gut microbiome composition as a function of prebiotic intake

  Increase in diversity of gut bacteria in the prebiotics group (number of different bacteria) in comparison to the placebo group. Based on stool sample analyses and microbiome sequencing.

  4 weeks of intervention

Study Arms (2)

Galacto-oligosaccharides (GOS) Group

EXPERIMENTAL

Participants in this group will receive the daily dosage of galacto-oligosaccharides (GOS) prebiotic for 4 weeks

Dietary Supplement: Galacto-oligosaccharides

Maltodextrin Group

PLACEBO COMPARATOR

Participants in this group will receive the daily dosage of Maltodextrin placebo for 4 weeks

Dietary Supplement: Maltodextrin

Interventions

Galacto-oligosaccharides DIETARY_SUPPLEMENT

GOS is a form of prebiotic, which enhance the growth of beneficial gut bacteria

Also known as: GOS

Galacto-oligosaccharides (GOS) Group

Maltodextrin DIETARY_SUPPLEMENT

sugar based placebo

Maltodextrin Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• University of Surrey: lead
• FrieslandCampina: collaborator

Study Sites (1)

University of Surrey

Guildford, Surrey, GU2 7XH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Kathrin Cohen Kadosh, PhD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathrin Cohen Kadosh, PhD

CONTACT

01483 68 3968; k.cohenkadosh@surrey.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Developmental Cognitive Neuroscience

Model Details: Participants will be randomly assigned into two groups. Group 1 will receive a daily dosage of GOS over 4 weeks, whereas group 2 will receive a placebo over the same period.

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 8, 2019
• Study Start: February 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2023
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)