Health TrialsbyHealthPanel

Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia

ConditionsFunctional DyspepsiaProbioticsDepressionAnxiety
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital of Digestive Diseases

About this trial

Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.

Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor.

The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.

Aged 18 to 80 years, regardless of gender.

Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.

Disqualifiers

Use of probiotics or antibiotics within one month prior to the trial.

Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.

Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.

Participation in any other clinical trial within one month prior to the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Clostridium butyricum

    Drug

    Patients with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily, along with Clostridium butyricum 1260 mg twice daily. Patients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Clostridium butyricum 1260 mg twice daily.

  • placebo

    Drug

    Patients with PDS will receive Mosapride Citrate Tablets 5 mg three times daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency). Patients with EPS will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency).

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: The probiotic groupExperimental treatment 1 intervention
Group B: The placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hospital Anxiety and Depression Scale (HADS)

Hospital Anxiety and Depression Scale (HADS) is divided into an anxiety subscale (7 questions) and a depression subscale (7 questions), with each subscale scoring 0-21 points. The higher the score, the more severe the patient's anxiety and depression.

Time frame
4 weeks

Secondary outcomes

1

Overall Treatment Evaluation (OTE) questionnaire

The OTE questionnaire uses the question "How have your stomach symptoms been in the past week compared to the baseline period?" scored on a 7-point Likert scale, with options of "extremely improved," "improved," "slightly improved," "unchanged," "slightly aggravated," "aggravated," or "extremely aggravated." If the patient answers "extremely improved" or "improved," it is considered a response, otherwise it is considered an unresponsive.

Time frame
4 weeks
2

Global Overall Symptom scale (GOS score)

The GOS score evaluates 10 types of gastrointestinal symptoms, with each symptom scoring 1-7 points and a total score of 10-70 points. The higher the score, the more severe the symptoms.

Time frame
4 weeks
3

Short-form Nepean Dyspepsia Index (SF-NDI)

Use Short-form Nepean Dyspepsia Index (SF-NDI) to evaluate the quality of life of patients, which includes 10 questions. Each question scores 1-5 points. The higher the score, the worse the quality of life.

Time frame
4 weeks
4

Pittsburgh Sleep Quality Index (PSQI)

Pittsburgh Sleep Quality Index (PSQI) is a self-assessment scale used to evaluate sleep quality within the past month. It contains 7 components, each scored on a scale of 0-3, with a final total score range of 0-21. The higher the score, the worse the sleep quality.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xijing Hospital of Digestive Diseases

Lead sponsor

Source ClinicalTrials.gov
Apply now