UnknownNot Applicable

Effects of Fermented Rye Bran Products on Helicobacter Pylori (HP) Infection and Metabolic Risk Factors

China182 participantsStarted 2015-04

Plain-language summary

The investigators hypothesize that long-term fermented high-fibre rye intake may reduce the Helicobacter pylori infection through dampening inflammation and thereby leading to lower adherence of the bacteria to surfaces.The investigators further hypothesize that that inflammation could be a potential causal link between HP infection and insulin resistance, a risk factor for type 2 diabetes and cardiovascular disease.

Who can participate

Age range20 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Both men and women are eligible.
✓. Age: 20-70 years old.
✓. HP: 13C-urea breath test value（DOB）above 4.
✓. 50% of the participants should have BMI below or equal to 24 and 50% should have BMI above 24.
✓. Willing to consume test products for 12 weeks.

Exclusion criteria

✕. Smokers.
✕. In medication (except medication for mild hypertension).
✕. Having allergies or food intolerance.
✕. Having chronic disease, such as type 2 diabetes, cardiovascular disease and cancer.
✕. Diagnosis of peptic ulcer.
✕. Pregnancy or to be pregnant.
✕. Having travel plans in 4 months.

What they're measuring

HP infection

Timeframe: 6，12 and 24 weeks

Trial details

NCT IDNCT03103386

SponsorFudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-09

View on ClinicalTrials.gov More H. Pylori Infections trials