IBS - Irritable Bowel SyndromeU54_P3_CBTNCT05155631
Sex Differences in Effectiveness of CBT on IBS Project 3
A study testing COGNITIVE BEHAVIORAL THERAPY in people with IBS - Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- COGNITIVE BEHAVIORAL THERAPY
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2021to 19 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 to 55 years of age, inclusive.
- Diagnosis or symptoms of Irritable Bowel Syndrome (IBS) meeting ROME IV diagnostic criteria for IBS (all sub-types).
- Must be absent of red flags including unexplained weight loss, fevers, anemia or blood in stools.
- Females must be premenopausal menstruating females. If female and of childbearing potential must be not pregnant, post-partum or breast feeding for at least 6 months. Must have a negative urine test for pregnancy. Must be willing to avoid pregnancy and practice a non-hormonal birth control method such as abstinence, non-hormonal IUD's, or barrier method with spermicide, during the time of study enrollment. Subjects who are on hormonal based birth control (e.g OCP's or implants) will be allowed in the study as long as they still get a monthly menses so menstrual phase can be identified using ovulation kits.
- Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
- Ability to speak the English language fluently due to the standardized assessments involved.
Who cannot join
- Evidence of structural abnormality of the gastrointestinal tract. Exclusionary GI conditions include but are not limited to gastrointestinal surgery (exceptions: appendectomy, benign polypectomy, cholecystectomy).
- Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g., major heart disease, neurological disorders, inflammatory diseases such as IBD; esophagitis, celiac disease, gastrointestinal malignancy or obstruction, peptic, duodenal or gastric ulcer disease, etc.). Malignancy (other than localized skin cancer that has been resected) within the previous 5 years.
- Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, current ADD diagnosis, Post-traumatic Stress Disorder, Obsessive Compulsive disorder or current history of tobacco or alcohol abuse. Subjects with a history of DSMIV diagnosis of Anxiety or Depression in whom symptoms are not active, will be allowed but noted for post-hoc analysis.
- Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
- Subjects with current regular use of narcotics and or opioids. Use of centrally acting medications that will interfere with the neuroimaging testing (such as systemic steroids, opiate analgesics). Medications which alter GI motility and gastric pH will need to be stopped at least 72 hours prior to any physiologic test visit and during the baseline and treatment intervention. For this we will ask the subject to get approval from their own PCP to stop prior to any intervention. However, rescue medication of bisacodyl and loperamide will be allowed for prolonged constipation and diarrhea, respectively, during intervention periods but not during baseline or within 3 days of follow up MRI. For rescue medication, such as laxatives or antidiarrheal, we will ask to hold off use up to 3 days prior to collecting stool sample.
- Obesity (BMI >35)
Show all 16Show fewer
- Subjects with claustrophobia, metal implants, dental braces, large tattoos (e.g. full arm or back); making MRI safety not possible.
- History of heavy use of tobacco products or current use of more than 1/3 ppd.
- Plans to undergo a major medical intervention such a surgery within 6 months of enrollment or during the study, or had major surgery in last 6 months.
- Current or past history of chronic pain syndrome other than IBS in the IBS group (pain >6 months at any location).
- Use of antibiotics or probiotics within 3 months of the study enrollment or regular use of probiotics within 4 weeks of enrollment. (enrollment may be deferred)
- Subjects who currently actively practice CBT or have completed a CBT therapy within 2 years prior to enrolling.
- Must must have a score of ≥175 (at least moderate severity IBS) on the IB-SSS symptom severity scale completed at screening.
- Have an average abdominal pain of at least 3 on a 0-10 point scale where 0=no pain and 10=worst imaginable pain.
- Any other condition that the investigator believes would jeopardize the safety or rights of the subject or would render the subject unable to comply with the study protocol or make use of acquired data non-analyzable.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sex Related Differences in the Effect of Cognitive Behavioral Therapy (CBT) on Emotional Arousal and Salience Circuits and the Role of the Gut Microbiome
Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks.
The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms.
Read more
Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology.
In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.
Read the detailed description
A total of 150 adult IBS participants will be completed in years 1-4 of the proposed studies. These will be 50 males, 50 premenopausal females in the treatment arm (Cognitive behavioral therapy: CBT) and 50 in 'usual care' arm, all bowel habit subtypes.
Screening V1: All subjects will have a pre-screening using a study specific IRB approved prescreening tool (15-20 minutes). lf eligible and interested, the study team will send the ICF via email to the subject and then study team will review the ICF with the subject to determine understanding of study participation and risks/benefits. Subjects will sign and return to the coordinator by electronic/scan/fax methods. The study team will then send participants a short link of preliminary questionnaires via survey Monkey to further determine eligibility for participation and assist the clinician in obtaining accurate medical history as well as assess any risk factors of participation. When determined to be eligible, the study team will set up a video/zoom /phone meeting to complete the initial screening visit/medical and psychological history taking. This will take about 1.5 hour.
Subjects will come to the OCNSR center to complete the study screening, including a physical exam by the RN and RN/NP or MD. Upon arrival, they will date and sign the informed consent and have time to ask any questions. The physical exam will include vital signs, height, weight, and a ROS (review of systems). There will be a single blood sample taken of about 2 teaspoons to determine menstrual cycle (females) and if needed, there may be additional blood (about 1 tablespoon) for IBS-diarrhea or mixed predominance to rule out any other gastrointestinal disease similar to IBS symptoms. Subjects will be given sample collection items to take home for stool and diet diary collection. The stool sample will be collected when they return for the scheduled MRI within 1-3 weeks of screening. They will be given two unique de-identified online Survey Monkey links to complete before the MRI visit. One link is a Diet History Questionnaires (VioScreen) and the other is a group of questionnaires asking about symptoms (IBS), mood and general health and wellbeing. This visit will take about 1.5-2 hours.
MRI V2: Brain and Brainstem Data Acquisition: All participants will undergo a 70 minute structural, resting state, DTI and brain stem MRI scanning session. All subjects will be imaged on a Siemens 3 Tesla Prisma scanner housed at the UCLA Ahmanson-Lovelace Brain Mapping Center (ALBMC). Subjects will complete several state anxiety and symptom-measuring questionnaires upon arrival . Females will need to do daily urine test at home to identify their menstrual phase. When arriving to MRI they will give a urine sample for pregnancy testing and will be excluded if pregnant. A single blood sample will be collected via venipuncture for hormones, cell methylation and pro inflammatory cytokines (15-20 ccs). Subjects will return with their diet diary, stool and saliva (female) sample collections and have all samples reviewed by study coordinator, for viability and collection accuracy.
Scanning will follow parameters of the HBC (Human Brain Connectome) project with anterior and posterior views for each scan. They will have the structural MP Rage (gray matter imaging) scan (time ~14.5 minutes) and subjects can watch a movie of their choice during this scan.
Following this is 2 RSN (resting state) functional scan (total time ~12 minutes). Instructions verbatim are given to subject during the RSN to rest, relax and focus on the crosshair displayed on mirrored screen reflected on the head coil without going to sleep. Following the resting state scan the subject will be asked if they had any pain or discomfort anywhere that may have distracted the subject during the functional resting state and this will be documented on a subject chart.
The next scan is the DTI (diffusion tensor imaging) lasting approximately 10 minutes. Subjects can watch a movie of their choice during this scan.
This visit will take no more than 1.5-2 hours.
Subjects will then be randomized to CBT (66.5 % chance) or usual care (33.5 % chance). The CBT is described below. If usual care, the subject will not have any restrictions on subjects except that the study team will ask subjects not to start new therapies for IBS or new medicines unless it is deemed necessary by their PCP.
CBT: This structured educational and skills based intervention is carried out via internet instruction and individual practice. Subjects will be asked to log into the CBT site once per week for 8-10 weeks with each session lasting between 20 and 40 minutes. The content has been validated in a randomized internet-based CBT trial for IBS. The intervention does not entail any direct therapist contact or interaction with other patients or study participants. The intervention is hosted by Mahana Therapeutics Inc. (named Parallel TM) who is contracted by UCLA to provide the intervention. Following enrollment, each subject will receive a secure login for accessing the CBT site and no personally identifying information will be asked for or passed along to the site or Mahana Therapeutics. During the 8 week intervention period subjects will be contacted by a study coordinator for follow-up should they stop logging in to the web site and they will be able to contact a study coordinator with questions regarding the intervention, website access, etc.
A responder will be defined as a subject with IBS-SSS score change of ≥50 from baseline to end of treatment and corresponds to a clinically meaningful change in symptoms. Participants assigned to the Usual Care condition will have the same questionnaire, neuroimaging, biological and symptom assessments as those in CBT but will not have any specific intervention from the project.
There will be a short mid study SM questionnaire link to complete related to symptoms. After 8-10 weeks of CBT (within 2-3 weeks of completion) they will return for a post-CBT MRI visit identical to description above.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- COGNITIVE BEHAVIORAL THERAPY
- Keywords
- CBT, MRI, IBS
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COGNITIVE BEHAVIORAL THERAPYBehavioural
8-10 week self directed on line CBT program approved by FDA
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Treatment Arm | Experimental | Subjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion. Receives: Behavioral: COGNITIVE BEHAVIORAL THERAPY |
| Usual Care Arm | No intervention | Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Connectivity Between Brainstem Nuclei and the Salience, Emotional Arousal and Sensorimotor Networks Brain Networks.
ROI (Region of Interest)-to-ROI connection pairs from resting-state fMRI data were computed and extracted to test functional connectivity between brainstem nuclei (Bstem) and the salience (SN), emotional arousal (EAN), and sensorimotor (SMN) networks. Participant-level composite scores were calculated by averaging connectivity values (Z transformed R values) across all ROI pairs within each unique network target for a total of 10 intrinsic and extrinsic network connections. Pre to post treatment mean changes in these composite scores were tested for differences between the usual care and CBT treatment groups using apriori contrast analyses with in the frame work of a linear mixed effects model , i.e. (CBT BL - CBT Post) - (UsualCare BL - UsualCare Post). Results are reported as the estimate marginal mean difference (estimate) and standard error (SE), the t statistic, the probability (p) and the 5% False Discovery Rate corrected p value (q) , and Cohen's effect size D with 95% CIs.
Measured: Before and after completion of 10 weeks of intervention or usual care.
Irritable Bowel Symptom Severity Scale (IBSSS)
The IBSSS is a validated composite symptom measure for severity of IBS symptoms. It will be used to determine treatment responder (>50 point change pre to post treatment). Outcome measures the number of patients imporved in each groups (e.g. number of patients who had a >50pts change on IBS-SSS).
Measured: Before and after completion of 10 weeks of intervention or usual care.
Secondary outcomes (3)
Abundance of Clostridiales Taxa
Stool sample taken pre and post treatment will be processed according to standard laboratory procedures and levels of Clostridiales determined.
Measured: Through study completion, an average of 2 years 11 months
Level of Tryptophan Metabolites
Plasma sample taken pre and post treatment will be processed according to standard laboratory procedures and levels of tryptophan metabolites determined.
Measured: Through study completion, an average of 2 years 11 months
KYN/TR Ratio.
Plasma samples taken pre and post treatment will be processed according to standard laboratory procedures and KYN/TR ration determined.
Measured: Through study completion, an average of 2 years 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start18 Dec 2021
- Primary completion8 Nov 2024
- Study completion19 Nov 2024
Why it stopped: Early termination due to unexpected closure of Mahana app. This caused a premature end to study enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- CBT
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emeran Mayer, MD, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155631
- Sponsor's protocol ID
- IRB#20-001118
- Other IDs
- 1U54DK123755
- Acronym
- U54_P3_CBT
- Status last verified
- Oct 2026
- First submitted
- 11 Jun 2021
- Last updated
- 5 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Related Differences in the Effect of Cognitive Behavioral Therapy (CBT) on Emotional Arousal and Salience Circuits and the Role of the Gut Microbiome
- ClinicalTrials.gov ID
- NCT05155631
- Acronym / sponsor ID
- U54_P3_CBT / IRB#20-001118
- Conditions
- IBS - Irritable Bowel Syndrome
- Keywords
- CBT, MRI, IBS
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early termination due to unexpected closure of Mahana app. This caused a premature end to study enrollment.
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Dec 2021 (actual)
- Primary completion
- 8 Nov 2024 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Posted 5 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive Behavioral Therapy (CBT) is the most well researched and most effective treatment for IBS targeting the brain-gut-microbiome (BGM) axis, and preliminary data show that this therapeutic effect is associated with a reduction of brainstem connectivity with other brain networks.
The increased prevalence of IBS in women, the higher rate of comorbid non-GI pain conditions, as well as the higher prevalence in female IBS of increased sensitivity to a variety of internal and external stimuli (multisensory sensitivity) suggest the presence of important sex differences in some of these BGM mechanisms.
Research performed by UCLA SCOR during previous funding has established an increased responsiveness of the CRF-Locus Coeruleus (LCC) system in female IBS subjects, suggesting that this central noradrenergic brainstem system plays an important role in IBS pathophysiology.
In addition, the study team's earlier research has begun to identify clinical, functional and structural brain mechanisms that may underlie these sex effects. Based on the preliminary data, the overall goal of this project is to use CBT as a probe to study the relationship between specific disease-related alterations of the brain, the gut microbiome, and symptomatic outcome, and identify the role of sex differences in these relationships. Investigators will study male and female IBS patients before and after CBT using the advanced neuroimaging and microbiome technologies of the overall SCOR.
Detailed description
A total of 150 adult IBS participants will be completed in years 1-4 of the proposed studies. These will be 50 males, 50 premenopausal females in the treatment arm (Cognitive behavioral therapy: CBT) and 50 in 'usual care' arm, all bowel habit subtypes.
Screening V1: All subjects will have a pre-screening using a study specific IRB approved prescreening tool (15-20 minutes). lf eligible and interested, the study team will send the ICF via email to the subject and then study team will review the ICF with the subject to determine understanding of study participation and risks/benefits. Subjects will sign and return to the coordinator by electronic/scan/fax methods. The study team will then send participants a short link of preliminary questionnaires via survey Monkey to further determine eligibility for participation and assist the clinician in obtaining accurate medical history as well as assess any risk factors of participation. When determined to be eligible, the study team will set up a video/zoom /phone meeting to complete the initial screening visit/medical and psychological history taking. This will take about 1.5 hour.
Subjects will come to the OCNSR center to complete the study screening, including a physical exam by the RN and RN/NP or MD. Upon arrival, they will date and sign the informed consent and have time to ask any questions. The physical exam will include vital signs, height, weight, and a ROS (review of systems). There will be a single blood sample taken of about 2 teaspoons to determine menstrual cycle (females) and if needed, there may be additional blood (about 1 tablespoon) for IBS-diarrhea or mixed predominance to rule out any other gastrointestinal disease similar to IBS symptoms. Subjects will be given sample collection items to take home for stool and diet diary collection. The stool sample will be collected when they return for the scheduled MRI within 1-3 weeks of screening. They will be given two unique de-identified online Survey Monkey links to complete before the MRI visit. One link is a Diet History Questionnaires (VioScreen) and the other is a group of questionnaires asking about symptoms (IBS), mood and general health and wellbeing. This visit will take about 1.5-2 hours.
MRI V2: Brain and Brainstem Data Acquisition: All participants will undergo a 70 minute structural, resting state, DTI and brain stem MRI scanning session. All subjects will be imaged on a Siemens 3 Tesla Prisma scanner housed at the UCLA Ahmanson-Lovelace Brain Mapping Center (ALBMC). Subjects will complete several state anxiety and symptom-measuring questionnaires upon arrival . Females will need to do daily urine test at home to identify their menstrual phase. When arriving to MRI they will give a urine sample for pregnancy testing and will be excluded if pregnant. A single blood sample will be collected via venipuncture for hormones, cell methylation and pro inflammatory cytokines (15-20 ccs). Subjects will return with their diet diary, stool and saliva (female) sample collections and have all samples reviewed by study coordinator, for viability and collection accuracy.
Scanning will follow parameters of the HBC (Human Brain Connectome) project with anterior and posterior views for each scan. They will have the structural MP Rage (gray matter imaging) scan (time ~14.5 minutes) and subjects can watch a movie of their choice during this scan.
Following this is 2 RSN (resting state) functional scan (total time ~12 minutes). Instructions verbatim are given to subject during the RSN to rest, relax and focus on the crosshair displayed on mirrored screen reflected on the head coil without going to sleep. Following the resting state scan the subject will be asked if they had any pain or discomfort anywhere that may have distracted the subject during the functional resting state and this will be documented on a subject chart.
The next scan is the DTI (diffusion tensor imaging) lasting approximately 10 minutes. Subjects can watch a movie of their choice during this scan.
This visit will take no more than 1.5-2 hours.
Subjects will then be randomized to CBT (66.5 % chance) or usual care (33.5 % chance). The CBT is described below. If usual care, the subject will not have any restrictions on subjects except that the study team will ask subjects not to start new therapies for IBS or new medicines unless it is deemed necessary by their PCP.
CBT: This structured educational and skills based intervention is carried out via internet instruction and individual practice. Subjects will be asked to log into the CBT site once per week for 8-10 weeks with each session lasting between 20 and 40 minutes. The content has been validated in a randomized internet-based CBT trial for IBS. The intervention does not entail any direct therapist contact or interaction with other patients or study participants. The intervention is hosted by Mahana Therapeutics Inc. (named Parallel TM) who is contracted by UCLA to provide the intervention. Following enrollment, each subject will receive a secure login for accessing the CBT site and no personally identifying information will be asked for or passed along to the site or Mahana Therapeutics. During the 8 week intervention period subjects will be contacted by a study coordinator for follow-up should they stop logging in to the web site and they will be able to contact a study coordinator with questions regarding the intervention, website access, etc.
A responder will be defined as a subject with IBS-SSS score change of ≥50 from baseline to end of treatment and corresponds to a clinically meaningful change in symptoms. Participants assigned to the Usual Care condition will have the same questionnaire, neuroimaging, biological and symptom assessments as those in CBT but will not have any specific intervention from the project.
There will be a short mid study SM questionnaire link to complete related to symptoms. After 8-10 weeks of CBT (within 2-3 weeks of completion) they will return for a post-CBT MRI visit identical to description above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- CBT
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Treatment Arm | Experimental | Behavioral: COGNITIVE BEHAVIORAL THERAPYSubjects in the "Cognitive Behavioral Treatment" Arm will undergo 8-10 weeks of remote cognitive behavioral therapy. Subjects will complete modules on their phones and will be monitored by study coordinators for support and treatment completion. |
| Usual Care Arm | No intervention | –Subjects in the "Usual Care" Arm will undergo 8-10 weeks of continued lifestyle. Subjects will be asked to report any new medications or lifestyle changes to study coordinators throughout the 8-10 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18 to 55 years of age, inclusive.
- Diagnosis or symptoms of Irritable Bowel Syndrome (IBS) meeting ROME IV diagnostic criteria for IBS (all sub-types).
- Must be absent of red flags including unexplained weight loss, fevers, anemia or blood in stools.
- Females must be premenopausal menstruating females. If female and of childbearing potential must be not pregnant, post-partum or breast feeding for at least 6 months. Must have a negative urine test for pregnancy. Must be willing to avoid pregnancy and practice a non-hormonal birth control method such as abstinence, non-hormonal IUD's, or barrier method with spermicide, during the time of study enrollment. Subjects who are on hormonal based birth control (e.g OCP's or implants) will be allowed in the study as long as they still get a monthly menses so menstrual phase can be identified using ovulation kits.
- Ambulatory outpatient (not depending exclusively on a wheelchair for mobility)
Key exclusion criteria (16 listed)
- Evidence of structural abnormality of the gastrointestinal tract. Exclusionary GI conditions include but are not limited to gastrointestinal surgery (exceptions: appendectomy, benign polypectomy, cholecystectomy).
- Presence of a significant and ongoing medical problem that would interfere with participation in the study or testing the study hypotheses (e.g., major heart disease, neurological disorders, inflammatory diseases such as IBD; esophagitis, celiac disease, gastrointestinal malignancy or obstruction, peptic, duodenal or gastric ulcer disease, etc.). Malignancy (other than localized skin cancer that has been resected) within the previous 5 years.
- Presence of a major psychiatric diagnosis such as schizophrenia, Bipolar disorder, current ADD diagnosis, Post-traumatic Stress Disorder, Obsessive Compulsive disorder or current history of tobacco or alcohol abuse. Subjects with a history of DSMIV diagnosis of Anxiety or Depression in whom symptoms are not active, will be allowed but noted for post-hoc analysis.
- Use of investigational drugs, products or devices within 28 days prior to screen and through study participation.
- Subjects with current regular use of narcotics and or opioids. Use of centrally acting medications that will interfere with the neuroimaging testing (such as systemic steroids, opiate analgesics). Medications which alter GI motility and gastric pH will need to be stopped at least 72 hours prior to any physiologic test visit and during the baseline and treatment intervention. For this we will ask the subject to get approval from their own PCP to stop prior to any intervention. However, rescue medication of bisacodyl and loperamide will be allowed for prolonged constipation and diarrhea, respectively, during intervention periods but not during baseline or within 3 days of follow up MRI. For rescue medication, such as laxatives or antidiarrheal, we will ask to hold off use up to 3 days prior to collecting stool sample.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COGNITIVE BEHAVIORAL THERAPY8-10 week self directed on line CBT program approved by FDA | Behavioural | Cognitive Behavioral Treatment Arm |
Primary outcome
Degree of Connectivity Between Brainstem Nuclei and the Salience, Emotional Arousal and Sensorimotor Networks Brain Networks.
Time frame: Before and after completion of 10 weeks of intervention or usual care.
ROI (Region of Interest)-to-ROI connection pairs from resting-state fMRI data were computed and extracted to test functional connectivity between brainstem nuclei (Bstem) and the salience (SN), emotional arousal (EAN), and sensorimotor (SMN) networks. Participant-level composite scores were calculated by averaging connectivity values (Z transformed R values) across all ROI pairs within each unique network target for a total of 10 intrinsic and extrinsic network connections. Pre to post treatment mean changes in these composite scores were tested for differences between the usual care and CBT treatment groups using apriori contrast analyses with in the frame work of a linear mixed effects model , i.e. (CBT BL - CBT Post) - (UsualCare BL - UsualCare Post). Results are reported as the estimate marginal mean difference (estimate) and standard error (SE), the t statistic, the probability (p) and the 5% False Discovery Rate corrected p value (q) , and Cohen's effect size D with 95% CIs.
Irritable Bowel Symptom Severity Scale (IBSSS)
Time frame: Before and after completion of 10 weeks of intervention or usual care.
The IBSSS is a validated composite symptom measure for severity of IBS symptoms. It will be used to determine treatment responder (>50 point change pre to post treatment). Outcome measures the number of patients imporved in each groups (e.g. number of patients who had a >50pts change on IBS-SSS).
3 secondary outcomes
Abundance of Clostridiales Taxa
Time frame: Through study completion, an average of 2 years 11 months
Level of Tryptophan Metabolites
Time frame: Through study completion, an average of 2 years 11 months
KYN/TR Ratio.
Time frame: Through study completion, an average of 2 years 11 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COGNITIVE BEHAVIORAL THERAPY in people with IBS - Irritable Bowel Syndrome, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of Connectivity Between Brainstem Nuclei and the Salience, Emotional Arousal and Sensorimotor Networks Brain Networks. (time frame: Before and after completion of 10 weeks of intervention or usual care.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.