Effect of Gastrogenic Microbiota in FD

NCT06760897 | Completed

• 1 other identifier: NFEC-2024-670
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in FD patients without Helicobacter pylori infection, compared to a placebo group

Conditions

Dyspepsia; Dysbiosis

Outcome Measures

Primary Outcomes (1)

• The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo

  The rate of relief of functional dyspepsia symptoms in Lactobacillus vs. placebo \[Time Frame: 8 weeks\] (using the the Patient Assessment of Upper Gastrointestinal Symptom Severity Index PAGI-SYM).The PAGI-SYM scale is specifically developed for the assessment of functional upper gastrointestinal diseases and is used to evaluate the severity of symptoms associated with these diseases. The scale comprises 21 symptoms of functional upper gastrointestinal diseases, with each symptom rated on a scale from none to very severe, scored as 0, 1, 2, 3, 4, or 5, respectively. The total score is calculated and used to assess the severity of functional upper gastrointestinal diseases.

  8 weeks

Secondary Outcomes (7)

• Changes in the Clinical Rating Scale for The Gastrointestinal Symptoms Rating Scale (GSRS) scores in the Lactobacillus vs. the placebo.

  8 weeks

• Changes in the Quality of Life scores (PAGI-QOL) in the Lactobacillus vs. the placebo.

  8 weeks

• Changes in the Self-Rating Anxiety Scale (SAS) scores in the Lactobacillus vs. the placebo.

  8 weeks

• Changes in the Self-Rating Depression Scale (SDS) scores in the Lactobacillus vs. the placebo.

  8 weeks

• Differences in the composition of gastric mucosal and fecal microbiota before and after treatment in the probiotic group

  8 weeks

Study Arms (2)

cohort 1FD

EXPERIMENTAL

Receiving 8 weeks of Gastrogenic Microbiota

Dietary Supplement: Gastrogenic Microbiota

cohort 2FD

PLACEBO COMPARATOR

Receiving 8 weeks of placebo

Other: Placebo

Interventions

Gastrogenic Microbiota DIETARY_SUPPLEMENT

Take 1 sachet of gastric-origin probiotic powder (containing 5 x 1011 CFU per sachet) twice daily for 8 weeks.

cohort 1FD

Placebo OTHER

similar powder administered twice daily

cohort 2FD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 and ≤70 years, with symptoms such as upper abdominal pain or burning sensation, postprandial bloating, early satiety, etc., and who meet the diagnostic criteria for functional dyspepsia (FD) according to the Rome IV criteria.
• Negative result on the C13 urea breath test, and no organic changes observed on gastroscopy.

You may not qualify if:

• Use of acid-suppressing drugs, prokinetic agents, antibiotic or anxiolytics within 4 weeks prior to enrollment.
• History of abdominal surgery, abdominal or inflammatory bowel disease, diabetes, active psychiatric disorders, or severe diseases of vital organs such as the heart, lungs, liver, or kidneys.
• Pregnant or breastfeeding participants, or those currently involved in other clinical research studies.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

NanfangH

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Dyspepsia; Dysbiosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: participants, care providers, and investigators are blinded during the randomized placebo-controlled phase (8 weeks)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized placebo-controlled study in 2 parallel FD cohorts

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: January 7, 2025
• Study Start: December 31, 2024
• Primary Completion: November 28, 2025
• Study Completion: December 31, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)