Prevalence of Antihistamine Responsive Irritable Bowel Syndrome With Diarrhea

NCT04612803 | Unknown FDA Drug

• 1 other identifier: 2020-0193
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Irritable Bowel Syndrome; Dermatographism; Post-prandial Diarrhea

Keywords

IBS; irritable bowel syndrome; Dermatographism; post-prandial diarrhea; antihistamine

Outcome Measures

Primary Outcomes (1)

• IBS symptomy severity score

  ≥50 point in reduction of symptoms with antihistamines based on the IBS symptom severity scale (IBS-SSS). This validated scale contains 5 questions that measures on a 100 point scale (for a total of 500 points) the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life.

  135 days

Secondary Outcomes (1)

• IBS quality of life

  135 days

Study Arms (1)

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

Drug: Antihistamine

Interventions

Antihistamine 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

IBS-D + dermatographism

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a patient population of adults with chronic diarrhea that has been evaluated for the common causes and resulting with a diagnosis of exclusion: irritable bowel syndrome with diarrhea.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cincinnati: lead

Related Publications (9)

• 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.

  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.

  PMID: 31279076 BACKGROUND

• 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.

  PMID: 23621090 BACKGROUND

• Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998 Feb;43(2):400-11. doi: 10.1023/a:1018831127942.

  PMID: 9512138 BACKGROUND

• McHugh KR, Swamy GK, Hernandez AF. Engaging patients throughout the health system: A landscape analysis of cold-call policies and recommendations for future policy change. J Clin Transl Sci. 2018 Dec;2(6):384-392. doi: 10.1017/cts.2019.1.

  PMID: 31402985 BACKGROUND

• Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.

  PMID: 9146781 BACKGROUND

• 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.

  PMID: 19293784 BACKGROUND

• 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.

  PMID: 12870789 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Familial dermographism

Interventions

Histamine Antagonists

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Study Officials

• David Bernstein, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yashu Dhamija, MD

CONTACT

513-558-1051; dhamijyu@ucmail.uc.edu

Simin Zhang, MD

CONTACT

(513) 558-5526; zhang2sm@ucmail.uc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2021
• Last Updated: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share