NCT07253155Enrolling by invitation
Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 23 Sept 2025
- Start date
- 14 Oct 2025
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- University of Ulster
- Diseases
- Obesity
- NCT number
- NCT07253155
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 14 Oct 2025 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Taking medication affecting the gastro-intestinal tract
Other illness
- Chronic gastro-intestinal illness
Age
- Not aged 40+ years (if have a BMI 25-29.9 kg/m2)
- BMI\<30 kg/m2 (if aged 18-39 years)
Other
- Pregnant/lactating female
- Vegan/vegetarian/high protein diet
- Taking fibre supplements or any probiotic or prebiotic products
- Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)
Who the study is looking for
- 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%)
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ulster University, Human Intervention Studies Unit Coordinator of this site? Confirm its status | Coleraine | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.