NCT04488198

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Mar 2019Dec 2026

Study Start

First participant enrolled

March 1, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

October 3, 2025

Status Verified

October 1, 2025

Enrollment Period

7.8 years

First QC Date

June 26, 2020

Last Update Submit

October 1, 2025

Conditions

Morbus CrohnColitis, Ulcerative

Outcome Measures

Primary Outcomes (2)

  • 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)

    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)

    At beginning vs 4 weeks

Secondary Outcomes (12)

  • Quality of Life in Children and Adolescents measured by KINDL(R)

    At beginning vs 4 weeks

  • Quality of Life in Children and Adolescents measured by KINDL(R)

    At beginning vs 8 weeks

  • Quality of Life in Children and Adolescents measured by ILK

    At beginning vs 4 weeks

  • Quality of Life in Children and Adolescents measured by ILK

    At beginning vs 8 weeks

  • Pain assessment

    At beginning vs 4 weeks

  • +7 more secondary outcomes

Study Arms (3)

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).

Other: Acupuncture

Placebo group

PLACEBO COMPARATOR

20 CIBD patients receive 8 sessions of sham acupuncture with placebo-needles 0,3 x 30mm (Streitberger).

Other: Placebo-Acupuncture

Interventions

AcupunctureOTHER

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.

Acupuncture group
Placebo-AcupunctureOTHER

Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.

Placebo group

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • mild/moderate CIBD
  • stable pharmacological treatment at least for 8 weeks

You may not qualify if:

  • complementary alternative medicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia, General Intensive Care and Pain Management,Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Crohn DiseaseColitis, Ulcerative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Gisela Scharbert, MD

    MedUniVienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Christina Hafner

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 27, 2020

Study Start

March 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

October 3, 2025

Record last verified: 2025-10

Locations

AU(1)