Prevalence of Antihistamine Responsive Irritable Bowel Syndrome With Diarrhea

NCT ID: NCT04612803

Last Updated: 2020-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-15
• Study Completion Date: 2021-08-01

Brief Summary

Irritable bowel syndrome is a functional disorder of the gastrointestinal tract diagnosed with the Rome criteria. The Rome IV criteria are based on abdominal pain symptoms and stool habits including stool frequency and stool forms [1]. They define 3 main subtypes based on symptoms: 1) IBS with diarrhea; 2) IBS with constipation: and 3) mixed symptoms of constipation and diarrhea. The IBS with diarrhea (IBS-D) subtype has the highest prevalence. Currently, treatment of IBS-D includes antidiarrheals, bile acid sequestrants, antispasmodics, tricyclic antidepressants, and FODMAP diet. However, many patients are intolerant or unresponsive to the above treatments. Outside of IBS, chronic diarrhea affects about 5% of adults. We have described a syndrome in a subset of IBS patients presenting with post prandial diarrhea, flushing and dermatographia whose symptoms are prevented by pre-treatment with combined H1 and H2 antihistamines [2]. However, the prevalence of this syndrome among the IBS + D patients is not known nor have the clinical characteristics or predictors of antihistamine responsive IBS + D been defined.

Detailed Description

We have published a series of 5 patients with chronic post prandial diarrhea (PPD) that begins within 3 hours after eating, associated with dermatographia, responsive to antihistamines [2]. In these cases, no underlying causes were identified to explain PPD; diagnoses of food allergy, lactose intolerance, celiac disease, dumping syndromes, inflammatory bowel disease, systemic mastocytosis were excluded. Patients with the syndrome have prior histories of chronic urticaria and experience associated transient symptoms of flushing, headache, tachycardia, and abdominal bloating during PPD episodes.

This syndrome, except for our published report, have not been previously described in the medical literature. Patients with systemic mastocytosis and mast cell activation syndrome experience PPD but along with anaphylactic manifestations (e.g. wheezing, hypotension) and measurable mast cell biomarkers are identifiable in affected patients (i.e. serum mast cell tryptase or 24 hour urine methylhistamine, PGF2a). Therefore, it is important to characterize PPD responsive to antihistamines in a general GI patient population and to publish our findings. The impact on human health will be substantial; we found that these patients are undiagnosed and untreated for many years.

Our aim is to recruit 50-100 patients from the UC Health affiliated gastroenterology clinics with access UC health which has 300-500 potential subjects. We would need to recruit 10-20% percentage of these potential subjects. Kris Ramprasad MD, a faculty member in the Division of Gastroenterology, David Bernstein MD, a faculty member in the Division of Allergy and Rheumatology, allergy fellows and GI fellows will direct and implement subject screening and consenting.

Conditions

Irritable Bowel Syndrome; Dermatographism; Post-prandial Diarrhea

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

IBS-D + dermatographism

IBS-D patients with dermatographism. Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after the morning dose for 30 days

Antihistamine

Intervention Type: DRUG

Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after the morning dose for 30 days

Interventions

Antihistamine

Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after the morning dose for 30 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older
• Prior to Diagnosis of IBS + diarrhea based on ICD 10 codes with or without constipation unresponsive to prior treatments
• Moderate to severe symptom severity score (>175 points) based on IBS symptom severity scale
• Seeking evaluation by a health care professional
• Negative serologic celiac panel
• No response to lactose elimination diet by history
• Normal colonoscopy
• Able to complete symptoms diaries and global evaluations

Exclusion Criteria

• Confirmed IgE dependent food allergy as a cause of the gastrointestinal symptoms.
• Lactose intolerance by history
• Celiac disease by serology
• Inflammatory bowel disease or colitis
• Bile acid diarrhea by history
• Post-surgical GI symptoms (e.g., dumping syndrome) by history
• No colonoscopy performed
• GI malabsorption
• Current pregnancy
• Current severe depression or history of psychosis
• Current treatment with tricyclic antidepressants

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

David Bernstein

Emeritus Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Central Contacts

Yashu Dhamija, MD

Role: CONTACT

dhamijyu@ucmail.uc.edu

513-558-1051

Simin Zhang, MD

Role: CONTACT

zhang2sm@ucmail.uc.edu

(513) 558-5526

References

Functional Gastrointestinal Disorders and the Rome IV process. In: Drossman DA, Chang L, Chey WD, Kellow J, Tack J, Whitehead WE, editors. Rome IV functional gastrointestinal disorders: disorders of gut-brain interaction.

Reference Type: BACKGROUND

Hassoun Y, Stevenson MR, Bernstein DI. Idiopathic postprandial diarrhea responsive to antihistamines. Ann Allergy Asthma Immunol. 2019 Oct;123(4):407-409. doi: 10.1016/j.anai.2019.06.022. Epub 2019 Jul 3. No abstract available.

Reference Type: BACKGROUND

PMID: 31279076 (View on PubMed)

Mlynek A, Vieira dos Santos R, Ardelean E, Weller K, Magerl M, Church MK, Maurer M. A novel, simple, validated and reproducible instrument for assessing provocation threshold levels in patients with symptomatic dermographism. Clin Exp Dermatol. 2013 Jun;38(4):360-6; quiz 366. doi: 10.1111/ced.12107.

Reference Type: BACKGROUND

PMID: 23621090 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Passos MC, Lembo AJ, Conboy LA, Kaptchuk TJ, Kelly JM, Quilty MT, Kerr CE, Jacobson EE, Hu R, Friedlander E, Drossman DA. Adequate relief in a treatment trial with IBS patients: a prospective assessment. Am J Gastroenterol. 2009 Apr;104(4):912-9. doi: 10.1038/ajg.2009.13. Epub 2009 Mar 17.

Reference Type: BACKGROUND

PMID: 19293784 (View on PubMed)

Gordon S, Ameen V, Bagby B, Shahan B, Jhingran P, Carter E. Validation of irritable bowel syndrome Global Improvement Scale: an integrated symptom end point for assessing treatment efficacy. Dig Dis Sci. 2003 Jul;48(7):1317-23. doi: 10.1023/a:1024159226274.

Reference Type: BACKGROUND

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B O'Neil, Some useful moment results in sampling problems. American Statistician Volume 69, Issue 4, 2014

Reference Type: BACKGROUND

Other Identifiers

2020-0193

Identifier Type: -

Identifier Source: org_study_id