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

NCT07253155 | Enrolling By Invitation

• 1 other identifier: REC/25/0042
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Obesity; gut inflammation; gastrointestinal symptoms; microbiota; metabolome; overweight

Outcome Measures

Primary Outcomes (1)

• Assess effects of FX856 on faecal calprotectin

  The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.

  Change over 28 days comparison between treatments

Secondary Outcomes (11)

• Assess effect of FX856 treatment on gastrointestinal symptoms

  Change over 28 days comparison between treatments

• Assess effect of FX856 on circulating inflammatory cytokines IFN-γ

  Change over 28 days comparison between treatments

• Assess effect of FX856 on circulating inflammatory cytokines IL-1β

  Change over 28 days comparison between treatments

• Assess effect of FX856 on circulating inflammatory cytokines IL-6

  Change over 28 days comparison between treatments

• Assess effect of FX856 on circulating inflammatory cytokines TNF-α

  Change over 28 days comparison between treatments

Study Arms (2)

Probiotic Arm

EXPERIMENTAL

Probiotic supplement arm, 2 capsules consumed/day for a period of 28 days.

Dietary Supplement: Probiotic Arm

Placebo Arm

PLACEBO COMPARATOR

Placebo supplement arm, 2 capsules consumed/day for a period of 28 days.

Dietary Supplement: Placebo Arm

Interventions

Probiotic Arm DIETARY_SUPPLEMENT

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

Probiotic Arm

Placebo Arm DIETARY_SUPPLEMENT

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

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Either a BMI 25+ kg/m2 and be aged 40+ years or have a BMI 30+ kg/m2 and aged 18+ years
• Males and females (not currently pregnant/lactating)
• Omnivorous diet (consuming plant \& animal based foods)
• Not taking any medication affecting the gastro-intestinal tract
• No chronic gastro-intestinal illness
• Not using fibre supplements or any probiotic or prebiotic products, e.g., Fybogel, Actimel, kefir or kimchee for at least 6 weeks prior to study
• Not consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)

You may not qualify if:

• Not aged 40+ years (if have a BMI 25-29.9 kg/m2)
• BMI\<30 kg/m2 (if aged 18-39 years)
• Pregnant/lactating female
• Vegan/vegetarian/high protein diet
• Chronic gastro-intestinal illness
• Taking medication affecting the gastro-intestinal tract
• Taking fibre supplements or any probiotic or prebiotic products
• Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)

Sponsors & Collaborators

• University of Ulster: lead
• Ferryx Limited: collaborator

Study Sites (1)

Ulster University, Human Intervention Studies Unit

Coleraine, BT52 1SA, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Gill, PhD

  Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded to participants and researchers
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 28, 2025
• Study Start: October 14, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)