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Visceral Sensitivity in Women With BS and Sexual Dysfunction (IBS)

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ClinicalTrials.gov Identifier: NCT04716738
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : February 2, 2021
Sponsor:
Collaborators:
Miguel Motola Kuba
María de Fátima Higuera de la Tijera
Hector Batalla Casimiro
Yoshua Flores Bravo
Information provided by (Responsible Party):
Santiago Camacho, Hospital General de Mexico

Brief Summary:
This study aims to compare visceral rectal sensitivity and quality of life of 40 Irritable Bowel Syndrome women, with (20) and without sexual dysfunction (20). Both Irritable Bowel Syndrome (IBS) and sexual dysfunction (SD), decrease quality of life (QOL) separately, and only recently we have shown that quality of life decreases even more with both diseases. Thus, there is clinical evidence to search for a biological marker that explains this cumulative effect. Investigators will determine IBS using the Rome IV criteria, SD through the Female Sexual Function Index (FSFI) while and QOL through the Short Form-36 and the IBS-QOL. Visceral sensitivity will be evaluated by a barostat study: A small bag connected to a computer is placed in the rectum. This computer will insufflate air increasing the volume and simultaneously record the pressure inside the rectum; therefore investigators can simulate what happens when the stool reaches the rectum. The patient reports the first sensation, gas sensation, need to defecate and even pain. For patient protection the pressure will never exceed 50 mmHg and/or if any amount of pain is reported. To assess the effect of food on this visceral sensitivity, it is performed in 2 stages, fasting and 30 minutes after a standardized meal. The protocol will be carried out through 3 visits. First patients will be recruited; the diagnosis of IBS, SD, quality of life will be established and basic laboratory tests will be schedule before next visit. Second visit will be on day 7 of the menstrual cycle when investigators will carry out the barostat study and determination of blood´s sex hormones. The last visit is for the second barostat study on day 21 of the menstrual cycle with sex hormones measurement. This protocol will compare: Rectal pressure and volume for tone, first sensation, gas sensation, desire to defecate and pain, measure during fasting and postprandial periods in day 7 and 21 (estrogenic and progesterone phase) of the menstrual cycle. Other variables include (age, marital status, disease history, SF-36, IBS-QOL, etc.). This study aims to find a biological marker to explain the low QOL observed in daily clinical practice. This approach will allow us a more effective diagnosis and perhaps the creation of more effective therapeutic approaches to treat these patients. In the long term, we expect to establish the foundations of a patient-centered medicine with shared decision more effective in the gut brain axis disorders.

Condition or disease Intervention/treatment
Irritable Bowel Syndrome Sexual Dysfunction Diagnostic Test: Blood analyses and coprological

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Sexual Satisfaction, Quality Of Life And Visceral Hyperalgesia In Women With Irritable Intestine Syndrome
Estimated Study Start Date : February 1, 2021
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 1, 2021

Group/Cohort Intervention/treatment
Irritable Bowel Syndrome with Sexual Dysfunction
We use Rome IV criteria, scale bristol and the female sexual fuction to establish IBS and sexual dysfunction diagnosis, and SF-36 to determinated quality of life.
Diagnostic Test: Blood analyses and coprological
We will take a blood and stool sample

Irritable Bowel Syndrome without Sexual Dysfunction
We use Rome IV criteria, scale bristol and the female sexual fuction to establish IBS and sexual dysfunction diagnosis, and SF-36 to determinated quality of life.
Diagnostic Test: Blood analyses and coprological
We will take a blood and stool sample




Primary Outcome Measures :
  1. Change on barostat study during menstrual cycle [ Time Frame: Second and third visit: Day 7 and day 21 of the menstrual cycle ]
    In this procedure, a small bag is placed in the rectum which is connected to a computer. This computer will insufflate air (in mL), measuring the pressure (in mmHg) inside the viscus (in this case the rectum) all time. With this system, a very precise feedback system is created allowing decrease or increase the pressure inside the rectum and thereby provoke the perception in the patient of different sensations. With the barostat we can simulate what happens when the stool reaches the rectum. Thus, the patient can report a first sensation, gas sensation, the need to defecate and even pain (mild, moderate or intense)


Secondary Outcome Measures :
  1. General Quality of Life questionnaire (SF-36, Short Form-36) [ Time Frame: Baseline ]
    This questionnaire consists of 36 questions that evaluate 8 domains (Items): physical function (10), physical role (4), body pain (2), general health (5), vitality (4), social function (2), role emotional (3) and mental health (5). Additionally, the SF-36 has a transition item that asks about the change in general health status compared to the previous year. Items are coded, aggregated and transformed on a scale from 0 (worst health status for that dimension) to 100 (best health status). Scores for the physical and emotional scale can also be calculated through an orthogonal approach

  2. Specific Quality of Life questionnaire (IBS-QOL, Irritable Bowel Syndrome-Quality of Life) [ Time Frame: Baseline ]
    This questionnaire consists of 34 questions on a Likert scale from 1 to 5. It measures a total score and 8 dimensions (items): Dysphoria (8), interference with activity (7), body image (4), concern for health ( 3), food avoidance (3), social reaction (4), sexual concern (2) and social relationship (3). The total score and the scores in each dimension are converted on a scale from 0 to 100. Higher values indicate a better health-related quality of life



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with irritable bowel syndrome with and without sexual dysfunction who are cared for in the gastroenterology service of the general hospital of Mexico.
Criteria

Inclusion Criteria:

  1. -18 Years And Older,
  2. -Meet The Diagnostic Criteria Of Roma Iv For Ibs ,
  3. - Agreeing To Participate In The Study And Sign Informed Consent

Exclusion Criteria:

  1. -Patient With Non-Ibs-Related Visceral Neuropathy
  2. - Prokinetic And/Or Antidepressant Treatment Within 3 Months
  3. - Patients With Gastrointestinal Or Ibs-Related Disease
  4. - Patients With Severe Heart, Kidney And/Or Systemic Diseases
  5. - Pregnant Or Nursing Patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04716738


Contacts
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Contact: Santiago Camacho, MD, MSc +525527462640 santiach@yahoo.com.mx
Contact: Miguel Motola, Researcher +525519484826 drmotola@gmail.com

Sponsors and Collaborators
Hospital General de Mexico
Miguel Motola Kuba
María de Fátima Higuera de la Tijera
Hector Batalla Casimiro
Yoshua Flores Bravo
Investigators
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Principal Investigator: Santiago Camacho, MD, MSc 6761
Publications:
Aziz I, Simrén M. Irritable Bowel Syndrome. In: Reference Module in Biomedical Sciences. Elsevier; 2019. Available at: https://www-sciencedirect-com.pbidi.unam.mx:2443/science/article/pii/B978012801238366018X [Accessed July 1, 2019].

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Responsible Party: Santiago Camacho, Principal Investigator, Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT04716738    
Other Study ID Numbers: DI/19/107/03/080
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Santiago Camacho, Hospital General de Mexico:
Visceral sensitivity
Barostat
Quality of life
Irritable Bowel Syndrome
Sexual dysfunction
Biological marker
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases