The interplay between the microbiota, diet and T regulatory cells in the preservation of the gut barrier in inflammatory bowel disease.
Kathryn Prame Kumar, Joshua D Ooi, Rimma Goldberg
https://pubmed.ncbi.nlm.nih.gov/38107848/Actively Recruiting
Led by Shanghai Institute of Acupuncture, Moxibustion and Meridian · Updated on 2026-04-13
106
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to improve the effectiveness of acupuncture in delaying the return of Crohns disease CD symptoms and to understand how acupuncture enhances treatment through the brain-gut axis. It builds on prior studies focusing on spleen and stomach support by exploring acupuncture targeting the Shaoyang pivot mechanism for better results. Brain-gut axis dysfunction plays a key role in CD, and this trial investigates multiple pathways involved in this process. Participants receive one of two acupuncture treatments combined with mild moxibustion, performed twice weekly for 12 weeks, followed by a 40-week follow-up. One group receives acupuncture aimed at harmonizing Shaoyang, nourishing spleen and kidney with warmth, while the other group receives acupuncture focused on nourishing spleen and kidney with warmth. Each treatment session lasts 30 minutes, where acupuncture and moxibustion are performed simultaneously, using specific acupoint combinations alternated between two sets. Throughout the study, participants are assessed regularly for disease recurrence and activity using clinical indexes such as the Crohns Disease Activity Index CDAI and patient-reported outcomes over 52 weeks. Laboratory tests, inflammation markers, colonoscopy or MR imaging, quality of life questionnaires, and mood assessments are conducted at multiple time points. Researchers monitor the proportion and timing of disease relapses, aiming to better understand acupunctures impact and mechanisms in CD management.
CONDITIONS
Acupuncture Reduces Relapse in Patients With Crohn's Disease: a Superiority Trial
B
Bao Chunhui, MD, PhD
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Shanghai Institute of Acupuncture, Moxibustion and Meridian
Lead Sponsor
Ruijin Hospital
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive acupuncture and mild moxibustion treatments twice per week for 12 weeks, targeting specific acupoints to help manage Crohn's disease.
Approximately 24 visits (in-person, twice weekly)
Duration - 40 weeks
Participants are followed for 40 weeks after treatment to monitor the effects and any recurrence of Crohn's disease symptoms.
Visits at Weeks 24, 36, and 52 for assessments
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
Ruijin Hospital
Collaborating Sponsor