96 Participants NeededMy employer runs this trial

Acupuncture for Irritable Bowel Syndrome

PM
HJ
Overseen ByHeidi Joyce
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether acupuncture can help children with gut-brain disorders, such as irritable bowel syndrome, feel better. It compares real acupuncture to a placebo version to determine any differences in pain reduction and quality of life improvement. Children aged 8-17 with specific stomach issues who have not tried acupuncture before may qualify. Participants will receive either real or placebo acupuncture alongside their usual care, and researchers will monitor changes in their symptoms. The goal is to discover a new way to help children manage these challenging conditions. As an unphased trial, this study provides a unique opportunity for children to explore an alternative treatment option that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial requires that participants have been on stable doses of antidepressant and/or ADHD medications for at least 8 weeks before joining. However, you must stop using ketamine, opioids, antibiotics, or probiotics at least 2 weeks before starting the trial.

What prior data suggests that acupuncture is safe for pediatric patients with DGBIs?

Research has shown that acupuncture is generally safe for treating irritable bowel syndrome (IBS). One study found acupuncture to be a practical and safe treatment for IBS, with no serious side effects. Another study demonstrated that acupuncture reduced symptoms like stomach pain, with benefits lasting for weeks, and participants found it easy to tolerate. These findings suggest that acupuncture is a safe option for managing IBS symptoms, with a low risk of negative effects.12345

Why are researchers excited about this trial?

Unlike the standard treatments for Irritable Bowel Syndrome (IBS), which often include dietary changes, medications like antispasmodics, and probiotics, acupuncture offers a unique approach by using precise needle insertion to potentially relieve symptoms. This ancient practice targets specific points on the body, believed to influence energy flow and alleviate pain, which is quite different from the pharmacological methods commonly used. Researchers are excited about acupuncture because it may provide a natural, non-drug alternative that could reduce IBS symptoms without the side effects often associated with medication. Additionally, the control group using sham acupuncture helps to ensure that any positive effects are truly due to the acupuncture itself, rather than a placebo effect.

What evidence suggests that acupuncture might be an effective treatment for irritable bowel syndrome?

Research has shown that acupuncture can help treat irritable bowel syndrome (IBS). One study found that acupuncture reduced stomach pain and improved stool consistency in IBS patients, with benefits lasting up to 18 weeks. Another study found acupuncture more effective than some medications for IBS, with effects lasting up to 12 weeks. Additionally, acupuncture has improved symptoms and quality of life for IBS patients. In this trial, participants will be divided into two groups: one receiving active acupuncture treatment and the other receiving a sham acupuncture treatment. These findings suggest that acupuncture might help reduce symptoms and enhance well-being for those with IBS.24678

Are You a Good Fit for This Trial?

This trial is for children aged 8-17 with irritable bowel syndrome, abdominal migraines, or functional abdominal pain. They must be medically stable, English-speaking, able to attend visits in Aliso Viejo, and not have had prior acupuncture or certain medications recently.

Inclusion Criteria

I have FAP-NOS, IBS, or abdominal migraines.
I have constipation and am on ongoing treatment after my symptoms improved.
Participant or Legally Authorized Representative (LAR) must have reliable transportation to attend study visits in Aliso Viejo
See 3 more

Exclusion Criteria

I have had IB-Stim and/or acupuncture before.
I have taken ketamine, opioids, codeine, Vicodin, antibiotics, or probiotics in the past month.
I have been diagnosed with functional dyspepsia.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either acupuncture or sham acupuncture once weekly for eight weeks

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Acupuncture

Trial Overview

The study compares real acupuncture to a sham (placebo) version in kids with gut-brain disorders like IBS. Participants are randomly assigned to either group and receive treatments alongside standard care over a set period.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: ActiveExperimental Treatment1 Intervention
Group II: Control/ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials
38
Recruited
5,700+

Citations

Efficacy of ACupuncTure in Irritable bOwel syNdrome ...

Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks. The results of this trial suggest that ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40441496/

Efficacy of ACupuncTure in Irritable bOwel syNdrome ...

Conclusions: Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks. The results of this trial ...

Effect of Acupuncture in Patients With Irritable Bowel ...

Conclusion. Acupuncture may be more effective than PEG 4000 or pinaverium bromide for the treatment of IBS, with effects lasting up to 12 weeks.

Effectiveness comparisons of acupoint stimulation ...

Our NMA results showed that the three acupoint stimulation intervention therapies were effective in reducing symptom severity and improving the quality of life ...

Acupuncture for the Treatment of Diarrhea-Predominant ...

In this pilot randomized clinical trial, acupuncture in both the SA and NSA groups showed clinically meaningful improvement in IBS-D symptoms.

The effect of acupuncture on quality of life in patients ... - PMC

The pooled result showed acupuncture can significantly improve the QoL of patients with IBS compared to the conventional treatment.

Effect of Acupuncture in Patients With Irritable Bowel ...

From baseline to 6 weeks, the total IBS-Symptom Severity Score decreased by 123.51 (95% CI, 116.61 to 130.42) in the acupuncture group and 94.73 (95% CI, 85.03 ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38958923/

Efficacy of acupuncture in refractory irritable bowel ...

From baseline to 4 weeks, the IBS-SSS total score decreased by 140.0 (95% CI: 126.0 to 153.9) in the acupuncture group and 64.4 (95% CI: 50.4 to ...