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New treatment option for Functional Constipation (FC)
Official title Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder
ClinicalTrials.gov ID: NCT07323407
What this study is testing
- What it's testing
- The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Diagnosis of Functional Constipation (FC): people must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.
- Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, people must have ≤2 complete spontaneous bowel...
- Poor Response to Previous Treatment: people must have been dissatisfied with prior treatments for functional constipation and have undergone at least...
- Diagnosis of Somatic Symptom Disorder (SSD): people must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All people will...
- Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.
You likely can't join if
- Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g...
- Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives...
- History of chronic pain or substance abuse, such as opioids;
- Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication...
- Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;
- History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver/kidney impairment or prolonged Q-T...
See the full eligibility criteria
Who can join
- Diagnosis of Functional Constipation (FC): people must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.
- Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, people must have ≤2 complete spontaneous bowel movements per week.
- Poor Response to Previous Treatment: people must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).
- Diagnosis of Somatic Symptom Disorder (SSD): people must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All people will undergo a semi-structured clinical interview based on DSM-5 criteria...
- Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.
- Criterion B: At least one of the following must be met:
- Excessive and persistent thoughts about the severity of symptoms;
- Persistently high levels of anxiety about health or symptoms;
- Excessive time and energy devoted to health concerns or symptoms.
- Criterion C: Symptoms must persist for at least 6 months.
- Age Range: people must be between 18 and 80 years old.
- No Concurrent Clinical Trials: people must not participate in any other clinical trials during the study period.
- Informed Consent: people must voluntarily agree to participate and sign an informed consent form.
What rules you out
- Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or...
- Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial...
- History of chronic pain or substance abuse, such as opioids;
- Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;
- Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;
- History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver/kidney impairment or prolonged Q-T interval on ECG;
- Pregnant or breastfeeding women;
- Patients with benign or malignant tumors or autoimmune diseases;
- Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations/treatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use...
The study team makes the final eligibility decision.
Where it's taking place
- Xi'an, Shaanxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xi'an, Shaanxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.