Morbus CrohnNCT04488198
Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
A study testing Acupuncture in people with Morbus Crohn and Colitis, Ulcerative, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Morbus Crohn, Colitis, Ulcerative
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2019to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mild/moderate CIBD
- stable pharmacological treatment at least for 8 weeks
Who cannot join
- complementary alternative medicine
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna
Vienna, 1090
About this study
Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. Additionally to conventional drugs one third of pediatric CIBD patients use alternative treatment strategies. However, there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the disease activity and inflammation. Therefore, the main aim of this study is to evaluate the effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are non-invasive validated instruments to measure the disease activity. Furthermore, this study aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters of inflammation.
- Conditions
- Morbus Crohn, Colitis, Ulcerative
- Being tested
- Acupuncture, Placebo-Acupuncture
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
Placebo-AcupunctureOther
Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 20 CIBD patients do not receive acupuncture or placebo-acupuncture. |
| Acupuncture group | Active comparator | 20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16). Receives: Other: Acupuncture |
| Placebo group | Placebo comparator | 20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger). Receives: Other: Placebo-Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Index
Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
Measured: At beginning vs 8 weeks
Disease Activity Index
Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
Measured: At beginning vs 4 weeks
Secondary outcomes (12)
Quality of Life in Children and Adolescents measured by KINDL(R)
The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.
Measured: At beginning vs 4 weeks
Quality of Life in Children and Adolescents measured by KINDL(R)
The quality of life will be measured using the KINDL(R) questionnaire. The data will be transformed according to the manual of the questionnaire. The total score of quality of life ranges from 0 to 100. A higher score is associated with a better quality of life.
Measured: At beginning vs 8 weeks
Quality of Life in Children and Adolescents measured by ILK
The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life.
Measured: At beginning vs 4 weeks
Quality of Life in Children and Adolescents measured by ILK
The quality of life will be also measured using the ILK questionnaire (Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen). The total score of quality ranges from 0 to 28. A higher score is associated with a better quality of life).
Measured: At beginning vs 8 weeks
Pain assessment
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Measured: At beginning vs 4 weeks
Pain assessment
The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).
Measured: At beginning vs 8 weeks
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Measured: At beginning vs 4 weeks
C reactive protein
As one parameter of inflammation the C reactive protein will be measured in mg/dl.
Measured: At beginning vs 8 weeks
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Measured: At beginning vs 4 weeks
Leukocytes
As another parameter of inflammation the leukocytes will be measured in 10^9/L
Measured: At beginning vs 8 weeks
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Measured: At beginning vs 4 weeks
Erythrocyte sedimentation rate
As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.
Measured: At beginning vs 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start1 Mar 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbus CrohnStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Hafner, Medical University of Vienna
- Investigators
- Gisela Scharbert, MD, Principal investigator, MedUniVienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488198
- Sponsor's protocol ID
- 1773/2018
- Status last verified
- Oct 2025
- First submitted
- 26 Jun 2020
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases
- ClinicalTrials.gov ID
- NCT04488198
- Acronym / sponsor ID
- 1773/2018
- Conditions
- Morbus Crohn, Colitis, Ulcerative
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic inflammatory bowel disease (CIBD) with its prevalence of 2.6 million people in Europe is diagnosed in 25% before the age of 18 years. Early remission is intended to improve child growth, quality of life and reduce psychological comorbidities. Additionally to conventional drugs one third of pediatric CIBD patients use alternative treatment strategies. However, there is a lack of evidence of acupuncture as complementary medicine in pediatric CIBD on the disease activity and inflammation. Therefore, the main aim of this study is to evaluate the effect of acupuncture in children with CIBD on the Pediatric Ulcerative Colitis Activity Index (PUCAI) and the Weighted Pediatric Crohn's Disease Activity Index (sPCDAI), which are non-invasive validated instruments to measure the disease activity. Furthermore, this study aims to investigate the effect of acupuncture on chronic pain, quality of life and parameters of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –20 CIBD patients do not receive acupuncture or placebo-acupuncture. |
| Acupuncture group | Active comparator | Other: Acupuncture20 CIBD patients receive 8 sessions of acupuncture therapy with 0,3 x 30mm needles (asia-med special number 16). |
| Placebo group | Placebo comparator | Other: Placebo-Acupuncture20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger). |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mild/moderate CIBD
- stable pharmacological treatment at least for 8 weeks
Key exclusion criteria (1 listed)
- complementary alternative medicine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupuncturePatients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles. | Other | Acupuncture group |
| Placebo-AcupuncturePatients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles. | Other | Placebo group |
Primary outcome
Disease Activity Index
Time frame: At beginning vs 8 weeks
Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
Disease Activity Index
Time frame: At beginning vs 4 weeks
Disease Activity Index (either Paediatric Ulcerative Colitis Activity Index in case of patients with ulcerative colitis or Weighted Pediatric Crohn's Disease Activity in patients with Crohn's disease)
12 secondary outcomes
Quality of Life in Children and Adolescents measured by KINDL(R)
Time frame: At beginning vs 4 weeks
Quality of Life in Children and Adolescents measured by KINDL(R)
Time frame: At beginning vs 8 weeks
Quality of Life in Children and Adolescents measured by ILK
Time frame: At beginning vs 4 weeks
Quality of Life in Children and Adolescents measured by ILK
Time frame: At beginning vs 8 weeks
Pain assessment
Time frame: At beginning vs 4 weeks
Pain assessment
Time frame: At beginning vs 8 weeks
C reactive protein
Time frame: At beginning vs 4 weeks
C reactive protein
Time frame: At beginning vs 8 weeks
Leukocytes
Time frame: At beginning vs 4 weeks
Leukocytes
Time frame: At beginning vs 8 weeks
Erythrocyte sedimentation rate
Time frame: At beginning vs 4 weeks
Erythrocyte sedimentation rate
Time frame: At beginning vs 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
Related trials for Morbus Crohn
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gisela Scharbert, MD principal investigator
MedUniVienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Morbus Crohn and Colitis, Ulcerative, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity Index (time frame: At beginning vs 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.