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The effect of three functional proteins on gastrointestinal health in Helicobacter pylori infected individuals

The effect of three functional proteins on gastrointestinal health in Helicobacter pylori infected individuals

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092806
Enrollment
Unknown
Registered
2024-11-24
Start date
2024-12-02
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Interventions

Bovine lactoferrin group:Bovine lactoferrin
Immunoglobulin group:Immunoglobulin
Egg yolk protein extract group:Egg yolk protein extract
Placebo control group:Dextrin

Sponsors

Lianshui People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age range: 20 to 70 years old. 2. Positive C13 Breath Test: Conducted after fasting or abstaining from food for 3 hours in the morning. Participants will orally ingest one 13C urea capsule (containing 75 mg of urea [13C] per capsule) with lukewarm water. After sitting quietly for 15 to 20 minutes, participants will breathe into a dedicated breath card, which is then inserted into a specialized detector to obtain the diagnosis result. The entire diagnostic process takes 25 minutes. A positive C13 Breath Test result is defined as a Delta over Baseline (DOB) value that is 4 times or more above the baseline (DOB = 4). 3. No antibiotic use within the past 4 weeks, no bismuth preparations or proton pump inhibitors within the past 2 weeks. 4. Possess normal comprehension and expression abilities. 5. Informed consent and voluntary participation in the study, with the ability to adhere to the study protocol during the research period and cooperate in completing all examinations required during the trial.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Individuals who have received antibiotics, antibacterial drugs, antiviral drugs, or immunotherapy within the past month. 3. Those supplemented with additional protein powder or other nutritional products within 3 weeks before the intervention. 4. Those allergic to eggs, milk, or other proteins. 5. Populations with fitness and fat-loss plans during the intervention period. 6. Individuals with a history of gastrointestinal surgery or severe gastrointestinal diseases. 7. Individuals with a history of organ transplantation or malignant tumors. 8. Participants who have engaged in other intervention studies within the past 30 days. 9. Individuals with indications for Helicobacter pylori (Hp) eradication therapy include those with gastric or duodenal ulcers, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, a family history of gastric cancer, and idiopathic iron deficiency anemia. 10. Individuals with severe medical conditions or conditions such as clinically significant (i.e., active) heart disease, severe and uncontrolled medical conditions, infections, severe and uncontrollable digestive system disorders, severe electrolyte disturbances, active disseminated intravascular coagulation, major organ failure such as decompensated heart, lung, liver, or renal failure, symptomatic peripheral neuropathy, etc.

Design outcomes

Primary

MeasureTime frame
Helicobacter pylori infection level (DOB);The three indicators of gastric function include Pepsinogen I (PGI), Pepsinogen II (PGII), the Pepsinogen Ratio (PGR, derived from PGI/PGII), and Gastrin-17;

Secondary

MeasureTime frame
The composition and metabolites of intestinal flora;Complete blood count;Blood biochemistry;Blood Immune Markers;

Countries

China

Contacts

Public ContactHu Qiaosheng

Lianshui People's Hospital

fox1921@163.com+86 517 8057 6256

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026