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Application of Hydrogen and methane-based breath testing in Diagnosis and Treatment of Digestive System Diseases

Application of Hydrogen and methane-based breath testing in Diagnosis and Treatment of Digestive System Diseases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100049277
Enrollment
Unknown
Registered
2021-07-29
Start date
2020-01-01
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

small intestinal bacterial overgrowth

Interventions

SIBO positive IBS patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive UC patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive Crohn patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive chronic pancreatitis patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive fatty liver patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive liver cirrhosis patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive colon polyps patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules
SIBO positive colorectal cancer patients:Rifaximin combined Live combined B.Subtilis and E.Faecium Enteric-coated capsules

Sponsors

the Sixth Medical Center of PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Irritable bowel syndrome: 1) Irritable bowel syndrome group (A1 group): (1) Aged 18 to 70 years old; (2) Meet the Rome IV IBS diagnostic criteria; (3) The clinician can exclude organic diseases after synthesizing the patient's clinical data; (4) Does not meet the diagnostic criteria of other functional gastrointestinal diseases; (5) Voluntary Joining this study, can accept questionnaire surveys and cooperate with breath test inspection requirements. 2) control group (A2) (1) Aged 18-70 years old; (2) Without obvious gastrointestinal symptoms (including: abdominal distension, abdominal pain, diarrhea, abdominal discomfort, obvious bowel, abnormal bowel movements, increased hiccups, etc.) in the past year. Patients without confirmed gastrointestinal diseases, and with no history of gastrointestinal or abdominal surgery; (3) There are no other diseases that may cause the disfunction of the gastrointestinal motility: such as diabetes, thyroid disease, chronic liver disease, connective tissue disease, nervous system disease, etc.; (4) Patients without serious heart, Liver, kidney and metabolic diseases; with no history of long-term drug use; with no history of hospitalization in the past six months; (5) Patients without history of heavy smoking or heavy drinking in the past year. 2. Ulcerative Colitis: 1)Ulcerative Colitis (B1 group) (1) aged 18-70 years old; (2) Meet the diagnostic criteria of ulcerative colitis (limited to mild and moderate) as diagnosed by the combination of the clinical manifestations and endoscopic pathological examinations; (3) Exclusion bacillary dysentery, amoebic dysentery, schistosomiasis, intestinal tuberculosis, Crohn's disease and radiation enteritis with stool culture and microscopy examination; (4) Voluntary Joining this study, can accept questionnaire surveys and cooperate with breath test inspection requirements. 2)Control group (B2) (1) aged 18-70 years old; (2) Without obvious gastrointestinal symptoms (including: abdominal distension, abdominal pain, diarrhea, abdominal discomfort, obvious bowel, abnormal bowel movements, increased hiccups, etc.) in the past year. Patients without confirmed gastrointestinal diseases, and with no history of gastrointestinal or abdominal surgery; (3) There are no other diseases that may cause the disfunction of the gastrointestinal motility: such as diabetes, thyroid disease, chronic liver disease, connective tissue disease, nervous system disease, etc.; (4) Patients without serious heart, Liver, kidney and metabolic diseases; with no history of long-term drug use; with no history of hospitalization in the past six months; (5) Patients without history of heavy smoking or heavy drinking in the past year. 3. Crohns disease: 1)Crohns disease group (C1 group) (1) aged 18-70 years old; (2) Meet the diagnostic criteria of Crohns disease (Remission period, moderate activity period) as diagnosed by the combination of the clinical manifestations and endoscopic pathological examinations; (3) Exclusion bacillary dysentery, amoebic dysentery, schistosomiasis, intestinal tuberculosis, Ulcerative Colitis and radiation enteritis with stool culture and microscopy examination; (4) Voluntary Joining this study, can accept questionnaire surveys and cooperate with breath test inspection requirements. 2)Control group (C2) (1) aged 18-70 years old; (2) Without obvious gastrointestinal symptoms (including: abdominal distension, abdominal pain, diarrhea, ab

Exclusion criteria

Exclusion criteria: 1. The exclusion criteria of the irritable bowel syndrome group (A1 group) and the control group (A2) (1) Patients with confirmed organic diseases of the digestive tract (such as tumors, inflammatory bowel disease, etc); (2) Patients with other organic diseases that may cause abnormal gastrointestinal function: such as diabetes, thyroid disease, chronic liver disease, connective tissue Diseases, nervous system diseases, etc.; (3) Patients with severe heart, liver, kidney, and metabolic diseases; previous history of abdominal trauma and surgery; (4) Use of antibiotics, microecological agents, lactulose, acid inhibitors or drug that affect gastrointestinal motility in the past 4 weeks; (5) Patients who underwent colonoscopy or enema, and patients who had acute enteritis within the past 2 weeks; (6) Patients who cannot express subjective discomfort symptoms or have severe mental illness; (7) Pregnant and lactating women; ?Patients who failed to prepare diet as required or cannot cooperate to complete the test. 2. The exclusion criteria of the Ulcerative Colitis group (B1 group) and the control group (B2) (1) Patients with bacillary dysentery, amoebic dysentery, schistosomiasis, intestinal tuberculosis, Crohns disease and radiation enteritis confirmed by stool culture and coloscopy; (2) Patients with other organic diseases that may cause abnormal gastrointestinal function: such as diabetes, thyroid disease, chronic liver disease, connective tissue Diseases, nervous system diseases, etc.; (3) Patients with severe ulcerative colitis, severe heart, liver, kidney, and metabolic diseases; previous history of abdominal trauma and surgery; (4) Use of antibiotics, microecological agents, lactulose, acid inhibitors or drug that affect gastrointestinal motility in the past 4 weeks; (5) Patients who underwent colonoscopy or enema, and patients who had acute enteritis within the past 2 weeks; (6) Patients who cannot express subjective discomfort symptoms or have severe mental illness; (7) Pregnant and lactating women; (8) Patients who failed to prepare diet as required or cannot cooperate to complete the test. 3. The exclusion criteria of the Crohns disease group (C1 group) and the control group (C2) (1) Patients with bacillary dysentery, amoebic dysentery, schistosomiasis, intestinal tuberculosis, Ulcerative Colitis and radiation enteritis confirmed by stool culture and coloscopy; (2) Patients with other organic diseases that may cause abnormal gastrointestinal function: such as diabetes, thyroid disease, chronic liver disease, connective tissue Diseases, nervous system diseases, etc.; (3) Patients with severe Crohns disease, severe heart, liver, kidney, and metabolic diseases; previous history of abdominal trauma and surgery; (4) Use of antibiotics, microecological agents, lactulose, acid inhibitors or drug that affect gastrointestinal motility in the past 4 weeks; (5) Patients who underwent colonoscopy or enema, and patients who had acute enteritis within the past 2 weeks; (6) Patients who cannot express subjective discomfort symptoms or have severe mental illness; (7) Pregnant and lactating women; (8) Patients who failed to prepare diet as required or cannot cooperate to complete the test. 4. The exclusion criteria of the Chronic pancreatitis group (D1 group) and the control group (D2) (1) Patients with confirmed diseases that may cause abdominal pain, fullness, nausea, flatulence, loss of appetite, oiliness, steatorrh

Design outcomes

Primary

MeasureTime frame
the Incidence of intestinal bacterial overgrowth;

Secondary

MeasureTime frame
Visual analog scale;

Countries

China

Contacts

Public ContactCui Lihong

The Sixth Medical Center of PLA General Hospital

luckycui861@sina.com+86 10 66957541

Outcome results

None listed

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