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Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.

NCT07253155 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-28

No results posted yet for this study

Summary

Inflammatory bowel disease (IBD) affects over 6.8 million people worldwide, with current treatments often causing side effects and poor patient compliance. Dysbiosis of gut microbiota is a key factor, and while probiotics are considered safe and beneficial, conventional strains fail to function effectively during active inflammation due to high iron levels in the gut. Streptococcus thermophilus (FX856), unlike traditional probiotics, can thrive in this iron-rich environment, promoting mucosal healing. A 2-way crossover intervention study will be conducted with FX856 supplementation in overweight and obese individuals who often exhibit mild gut inflammation by measuring faecal calprotectin and systemic inflammatory markers.

Conditions

  • Gut Inflammation
  • Overweight and Obese Volunteers

Interventions

DIETARY_SUPPLEMENT

Probiotic Arm

1 x10\^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.

DIETARY_SUPPLEMENT

Placebo Arm

corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.

Sponsors & Collaborators

  • Ferryx Limited

    collaborator UNKNOWN

  • University of Ulster

    lead OTHER

Principal Investigators

  • Chris Gill, PhD · Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-14
Primary Completion
2028-09-01
Completion
2028-09-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253155 on ClinicalTrials.gov