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NCT Number: NCT04488198

Acupuncture in Pediatrics and Adolescents With Chronic Inflammatory Bowel Diseases

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Morbus Crohn Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • complementary alternative medicine

Treatment and study plan

Acupuncture

Other

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

Placebo-Acupuncture

Other

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

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

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

    Time frame: At beginning vs 4 weeks

    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.

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

    Time frame: At beginning vs 8 weeks

    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.

  3. Quality of Life in Children and Adolescents measured by ILK

    Time frame: At beginning vs 4 weeks

    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.

  4. Quality of Life in Children and Adolescents measured by ILK

    Time frame: At beginning vs 8 weeks

    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).

  5. Pain assessment

    Time frame: At beginning vs 4 weeks

    The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).

  6. Pain assessment

    Time frame: At beginning vs 8 weeks

    The pain will be measured using the numerating scale, which ranges from 0 (no pain) to 10 (worst pain possible).

  7. C reactive protein

    Time frame: At beginning vs 4 weeks

    As one parameter of inflammation the C reactive protein will be measured in mg/dl.

  8. C reactive protein

    Time frame: At beginning vs 8 weeks

    As one parameter of inflammation the C reactive protein will be measured in mg/dl.

  9. Leukocytes

    Time frame: At beginning vs 4 weeks

    As another parameter of inflammation the leukocytes will be measured in 10^9/L

  10. Leukocytes

    Time frame: At beginning vs 8 weeks

    As another parameter of inflammation the leukocytes will be measured in 10^9/L

  11. Erythrocyte sedimentation rate

    Time frame: At beginning vs 4 weeks

    As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.

  12. Erythrocyte sedimentation rate

    Time frame: At beginning vs 8 weeks

    As another inflammatory parameter the erythrocyte sedimentation rate (mm/hour) will be measured.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 27, 2020
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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