NCT04554641

Brief Summary

Over recent years there has been a lot of research looking at how the bacteria in our gut affect our health. Changes to gut bacteria has been linked to several diseases. Taking specific live bacteria supplements (sometimes known as 'probiotics'), to change the balance of our gut bacteria to result in a health benefit have been trialled as a treatment option for many diseases in recent years. Bio-Kult Advanced is a live bacteria Food supplement that contains 14 different bacteria cultures. The effect of Bio-Kult Advanced on gut bacteria is unknown, therefore, the aim

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2021

Completed
Last Updated

February 16, 2021

Status Verified

February 1, 2021

Enrollment Period

1.3 years

First QC Date

September 4, 2020

Last Update Submit

February 15, 2021

Conditions

Microbial Colonization

Keywords

ProbioticsMicrobiomeGastrointestinal

Outcome Measures

Primary Outcomes (1)

  • Stool sample comparison

    Comparison between samples at different taxonomical levels (phylum, family, genus and species) will be performed for the identification of specific bacteria in samples of interest. Accumulative bar charts will be provided for rapid inspection. PCA and clustering will be conducted. Biodiversity Index (Shannon, Simpson, Gini-Simpson or Berger-Parker) will be calculated. Biostatistics will be done in order to detect biomarkers between timepoints of the study.

    56 days

Secondary Outcomes (2)

  • Fasting breath samples

    56 days

  • Bowel habit

    56 days

Study Arms (1)

BioKult Advanced

EXPERIMENTAL

This is a single arm study, all participants will take Bio-kult Advanced for 56 days (+/- 2days). Participants will be required to take 4 capsules daily.

Other: Fasted breath samplesOther: Daily DiaryOther: Stool sample

Interventions

Fasted breath samplesOTHER

Participants will provide fasted breath samples pre and post Bio-Kult Advanced.

BioKult Advanced
Daily DiaryOTHER

Monitoring stool form, consistency and frequency on a daily basis.

BioKult Advanced
Stool sampleOTHER

Participants will provide stool sample pre and post Bio-kult Advanced.

BioKult Advanced

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult males and females (50:50) between 18 to 40 years old
  • No significant medical diagnosis (healthy individuals)
  • Not on regular prescription medicines
  • No selective/restricted diets (e.g. vegan, low FODMAP)
  • Body Mass Index of 18.50-29.99 kg/m2
  • Participant able to understand the participant information sheet in English and provide informed consent

You may not qualify if:

  • Diagnosis of any medical condition, except for visual impairment and other conditions to clinicians discretion
  • Prior abdominal surgery (e.g. appendectomy, bariatric surgery )
  • Migraine as based on migraine definition by ICHD 2019:
  • A minimum of five attacks (in absolute terms) fulfilling criteria:
  • Duration 4 - 72 hours
  • At least two of the following:
  • unilateral location
  • pulsating character
  • moderate or severe pain intensity
  • aggravation by routine physical activity
  • Presence of nausea/vomiting OR photophobia/phonophobia during headache
  • Ongoing therapy with medication known to affect the gut microbiome:
  • Antibiotics used in the last 8 weeks
  • Proton pump inhibitors used in the last 8 weeks
  • Antidepressants in the last 8 weeks
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Functional Gut Clinic

Manchester, M2 4NG, United Kingdom

Location

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Hobson

    The Functional Gut Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Clinical Scientist

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 18, 2020

Study Start

November 1, 2019

Primary Completion

February 12, 2021

Study Completion

February 12, 2021

Last Updated

February 16, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)