Postoperative IleusCaCoNCT02510911
Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy?
A study testing Caffeine (100 mg), Caffeine (200 mg) and corn starch (250 mg approx.) in people with Postoperative Ileus and Laparoscopic Colectomy Without Stoma Formation, run by Thomas Steffen at 2 sites in Switzerland.
Trial summary
Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Ileus, Laparoscopic Colectomy Without Stoma Formation, Colorectal Neoplasm
- What is being tested?
- Caffeine (100 mg), Caffeine (200 mg) and corn starch (250 mg approx.)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2015to 22 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
- There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study.
- Informed consent
- Application of epidural analgesia
Who cannot join
- Participation in another concurrent interventional trial
- Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
- Known hypersensitivity or allergy to caffeine/coffee
- Expected lack of compliance
- American Society of Anesthesiologists (ASA) Physical Status Score of IV or V
- Impaired mental state or language problems
Show all 16Show fewer
- Alcoholism or drug abuse
- Previous extensive abdominal surgery
- Inflammatory bowel disease
- Clinically significant cardiac arrhythmia
- Cardiac insufficiency
- Pregnancy, lactation, or childbearing potential without using adequate contraception
- Intake of opioid analgesics, or steroids >5mg/d for ≥7 days before surgery
- Under anti-depressive medication
- Liver cirrhosis or compromised liver function (MELD score >15)
- Emergency procedure
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Rorschach, 9400
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
Sankt Gallen, 9007
About this study
Official title: Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent.
Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy?
Read more
Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.
The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints).
Primary endpoint will be the time to first bowel movement.
- Conditions
- Postoperative Ileus, Laparoscopic Colectomy Without Stoma Formation, Colorectal Neoplasm, Diverticulitis
- Being tested
- Caffeine (100 mg), Caffeine (200 mg), corn starch (250 mg approx.), Radiopaque marker
- Keywords
- colectomy, laparoscopy, caffeine
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine (100 mg)Drug
Also called coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2
Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals.
First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
Caffeine (200 mg)Drug
Also called coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2
Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals.
First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
corn starch (250 mg approx.)Drug
Also called Amylum maydis
Patients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals.
First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
Treatment consists of 10 capsules and will be stopped after the first solid bowel movement.
Radiopaque markerOther
Also called Colon Transit, PZN 3351272, GTIN Code 7629999004153
On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers .
On day 4 after surgery an abdominal X-ray will be performed to localize the markers.
Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%).
| Study group | Role | What they receive |
|---|---|---|
| Caffeine (100 mg) | Experimental | Verum 1 with 100 mg caffeine Receives: Drug: Caffeine (100 mg); Other: Radiopaque marker |
| Caffeine (200 mg) | Experimental | Verum 2 with 200 mg caffeine Receives: Drug: Caffeine (200 mg); Other: Radiopaque marker |
| corn starch (250 mg approx.) | Placebo comparator | approx. 250 mg corn starch as placebo Receives: Drug: corn starch (250 mg approx.); Other: Radiopaque marker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first bowel movement
Time from end of surgery (time of closing suture) until patient's first bowel movement (passage of stool) in hours.
A patient is considered to have met the primary endpoint when he or she had first tolerated food (recovery of upper GI function) and experienced a bowel movement for the first time (recovery of lower GI function).
Measured: 7 days
Secondary outcomes (18)
Time to first flatus
Time from end of surgery until patient's first flatus in hours. The passage of flatus will be determined by questioning the patient; the passage of a bowel movement will be determined by reference to nursing records or by the clinical judgment of the investigator or designee following questioning the patient.
Measured: 7 days
Time to tolerance of solid food
Time from end of surgery until patient tolerates intake of solid food in hours. Tolerance of food is defined as the first time the patient is able to eat solid food (any food re-quiring chewing) without vomiting or significant nausea within 4 h after the meal, and without reversion to only enteral fluids.
Measured: 7 days
Postoperative vomiting events
Number of times patient has to vomit.
Measured: 7 days
Colonic passage time
On day 1, 2 and 3 after surgery patients take one capsule with radioopaque markers. On day 4 location and count of markers is determined by X-ray imaging and the colonic passage time is determined (Metcalf 1987).
Measured: 4 days
Actual postoperative hospital stay
Number of days from surgery until actual discharge.
Measured: 30 days
Theoretical postoperative hospital stay
Days from surgery until patient would be fit for release. Often patients stay longer in hospital than clinically required. Thus, evaluation of theoretical hospital stay.
A patient is fit for release if:
- there had been bowel movement
- solid food is tolerated
- no serious pain
- unproblematic mobilisation
- surgical wound shows no sign of inflammation, or wound can be treated well in an outpatient setting
- normal inflammatory markers (≤135 mg/l C-reactive protein (CRP), ≤9 10⁹/l white blood cell count)
Measured: 30 days
Daily doses of analgetics
Amount, type, and time of application of analgetics will be obtained from medical and nursing records.
Measured: 30 days
Postoperative pain
evaluated on the numeric rating scale (0 - 10, steps of 1)
Measured: 7 days
Postoperative mobilization
Scoring:
- 0: 24 h in bed
- 1: Out of bed only to go to bathroom
- 2: Out of bed on free will
Measured: 7 days
Overall fluid intake
all fluids in ml per day
Measured: 7 days
Blood pressure
3 times daily
Measured: 7 days
Pulse
3 times daily (or more often if required)
Measured: 7 days
Intensive care
number of days in intensive care unit
Measured: 14 days
Well-being
well-being evaluating on day 2 and 4 after surgery using the Basle mental state scale as well as 5 additional items to evaluate the effects of caffeine. (Hobi 1985, Hobi 1989)
Measured: 4 days
Sleep behaviour
Leeds Sleep Evaluation Questionnaire (LSEQ) on day 2 and 4 after surgery. (Parrott 1986)
Measured: 4 days
Sleeping habits
Questionnaire evaluating duration and deepness of sleep.
Measured: 4 days
Satisfaction with surgery
Questionnaire on day 4 about satisfaction of treatment
Measured: 4 days
Consumption of sleep inducing drugs
amount and type of sleep inducing drugs
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2020
- Study completion22 Dec 2020
Why it stopped: lack of effect at interims analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Steffen
- Sponsor type
- University, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Responsible party
- Sponsor-investigator, Thomas Steffen, Cantonal Hospital of St. Gallen
- Investigators
- Thomas Steffen, MD, Principal investigator, Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510911
- Sponsor's protocol ID
- CaCo, Chir201401
- Acronym
- CaCo
- Status last verified
- Aug 2021
- First submitted
- 27 Jul 2015
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
PubMed 22987303Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7.
PubMed 3023168Hobi V, Gerhard U, Gutzwiller F. [A report on experiences using Goldberg's GHQ (General Health Questionnaire)]. Schweiz Rundsch Med Prax. 1989 Feb 28;78(9):219-25. German.
PubMed 2928619Hobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.
Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
PubMed 6777817Abbassi F, Muller SA, Steffen T, Schmied BM, Warschkow R, Beutner U, Tarantino I. Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial). Br J Surg. 2022 Nov 22;109(12):1216-1223. doi: 10.1093/bjs/znac265.
PubMed 35909263Kruse C, Muller SA, Warschkow R, Luthi C, Brunner W, Marti L, Sulz MC, Schmied BM, Tarantino I, Beutner U. Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial. Trials. 2016 Apr 4;17:186. doi: 10.1186/s13063-016-1297-1.
PubMed 27044596
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Caffeine Reduce Postoperative Bowel Paralysis After Elective Colectomy? - A Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02510911
- Acronym / sponsor ID
- CaCo / CaCo, Chir201401
- Conditions
- Postoperative Ileus, Laparoscopic Colectomy Without Stoma Formation, Colorectal Neoplasm, Diverticulitis
- Keywords
- colectomy, laparoscopy, caffeine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of effect at interims analysis
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thomas SteffenUniversity, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Study start
- Aug 2015
- Primary completion
- Aug 2020 (actual)
- Study completion
- 22 Dec 2020 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative bowel paralysis is common after abdominal operations, including colectomy. As a result, hospitalization may be prolonged leading to increased cost. A recent randomized controlled trial from the University of Heidelberg showed that consumption of regular black coffee after colectomy is safe and associated with a significantly faster resumption of intestinal motility (Müller 2012). The mechanism how coffee stimulates intestinal motility is unknown but caffeine seems to be the most likely stimulating agent.
Thus, this trial addresses the question: Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy?
Patients after laparoscopic colectomy will receive either 100 mg caffeine, 200 mg caffeine, or 250mg corn starch (placebo) 3 times daily in identically looking gelatin capsules.
The study is a randomized, controlled trial, with blinding of physicians, patients and nursing stuff (evaluating the endpoints).
Primary endpoint will be the time to first bowel movement.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Caffeine (100 mg) | Experimental | Drug: Caffeine (100 mg), Other: Radiopaque markerVerum 1 with 100 mg caffeine |
| Caffeine (200 mg) | Experimental | Drug: Caffeine (200 mg), Other: Radiopaque markerVerum 2 with 200 mg caffeine |
| corn starch (250 mg approx.) | Placebo comparator | Drug: corn starch (250 mg approx.), Other: Radiopaque markerapprox. 250 mg corn starch as placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for elective laparoscopic colectomy (right or left hemicolectomy, segmental resection, extended hemicolectomy, sigmoid resection, upper rectum (anastomosis higher than 7 cm ab ano))
- There will be no upper age limit. If elderly patients are considered fit for surgery, they will be included in the study.
- Informed consent
- Application of epidural analgesia
Key exclusion criteria (16 listed)
- Participation in another concurrent interventional trial
- Need for a stoma (colostomy or ileostomy) or reversal of a stoma, if the patient had a complete bowel obstruction
- Known hypersensitivity or allergy to caffeine/coffee
- Expected lack of compliance
- American Society of Anesthesiologists (ASA) Physical Status Score of IV or V
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 |
|---|---|---|
| Caffeine (100 mg)Also: coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement. | Drug | Caffeine (100 mg) |
| Caffeine (200 mg)Also: coffeinum, methyltheobromine, 1,3,7-trimethyl-3,7-dihydro-1H-purin-2,4-dion, CAS No: 56-08-2Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement. | Drug | Caffeine (200 mg) |
| corn starch (250 mg approx.)Also: Amylum maydisPatients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals. First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day. Treatment consists of 10 capsules and will be stopped after the first solid bowel movement. | Drug | corn starch (250 mg approx.) |
| Radiopaque markerAlso: Colon Transit, PZN 3351272, GTIN Code 7629999004153On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers . On day 4 after surgery an abdominal X-ray will be performed to localize the markers. Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%). | Other | Caffeine (100 mg), Caffeine (200 mg), corn starch (250 mg approx.) |
Primary outcome
Time to first bowel movement
Time frame: 7 days
Time from end of surgery (time of closing suture) until patient's first bowel movement (passage of stool) in hours. A patient is considered to have met the primary endpoint when he or she had first tolerated food (recovery of upper GI function) and experienced a bowel movement for the first time (recovery of lower GI function).
18 secondary outcomes
Time to first flatus
Time frame: 7 days
Time to tolerance of solid food
Time frame: 7 days
Postoperative vomiting events
Time frame: 7 days
Colonic passage time
Time frame: 4 days
Actual postoperative hospital stay
Time frame: 30 days
Theoretical postoperative hospital stay
Time frame: 30 days
Daily doses of analgetics
Time frame: 30 days
Postoperative pain
Time frame: 7 days
Postoperative mobilization
Time frame: 7 days
Overall fluid intake
Time frame: 7 days
Blood pressure
Time frame: 7 days
Pulse
Time frame: 7 days
Intensive care
Time frame: 14 days
Well-being
Time frame: 4 days
Sleep behaviour
Time frame: 4 days
Sleeping habits
Time frame: 4 days
Satisfaction with surgery
Time frame: 4 days
Consumption of sleep inducing drugs
Time frame: 7 days
Results and safety
The study was stopped early (reason given: lack of effect at interims analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 22987303Muller SA, Rahbari NN, Schneider F, Warschkow R, Simon T, von Frankenberg M, Bork U, Weitz J, Schmied BM, Buchler MW. Randomized clinical trial on the effect of coffee on postoperative ileus following elective colectomy. Br J Surg. 2012 Nov;99(11):1530-8. doi: 10.1002/bjs.8885. Epub 2012 Sep 14.
- Background: PubMed 3023168Metcalf AM, Phillips SF, Zinsmeister AR, MacCarty RL, Beart RW, Wolff BG. Simplified assessment of segmental colonic transit. Gastroenterology. 1987 Jan;92(1):40-7. doi: 10.1016/0016-5085(87)90837-7.
- Background: PubMed 2928619Hobi V, Gerhard U, Gutzwiller F. [A report on experiences using Goldberg's GHQ (General Health Questionnaire)]. Schweiz Rundsch Med Prax. 1989 Feb 28;78(9):219-25. German.
- BackgroundHobi V. Basler Befindlichkeits-Skala. Ein Self-Rating zur Verlaufsmessung der Befindlichkeit. Manual. 1 ed. Weinheim: Beltz Test GmbH, 1985.
- Background: PubMed 6777817Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations - a review. Psychopharmacology (Berl). 1980;71(2):173-9. doi: 10.1007/BF00434408.
- Derived from this study: PubMed 35909263Abbassi F, Muller SA, Steffen T, Schmied BM, Warschkow R, Beutner U, Tarantino I. Caffeine for intestinal transit after laparoscopic colectomy: randomized clinical trial (CaCo trial). Br J Surg. 2022 Nov 22;109(12):1216-1223. doi: 10.1093/bjs/znac265.
- Derived from this study: PubMed 27044596Kruse C, Muller SA, Warschkow R, Luthi C, Brunner W, Marti L, Sulz MC, Schmied BM, Tarantino I, Beutner U. Does caffeine reduce postoperative bowel paralysis after elective laparoscopic colectomy? (CaCo trial): study protocol for a randomized controlled trial. Trials. 2016 Apr 4;17:186. doi: 10.1186/s13063-016-1297-1.
- Web site of the Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen (German only)Link provided by the sponsor.
- 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.
Thomas Steffen, MD principal investigator
Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine (100 mg), Caffeine (200 mg) and corn starch (250 mg approx.) in people with Postoperative Ileus and Laparoscopic Colectomy Without Stoma Formation, run by Thomas Steffen at 2 sites in Switzerland.
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 4 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 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early (reason given: lack of effect at interims analysis). Results are not available in the source record.
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?
Time to first bowel movement (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02510911, which also lists 7 linked publications.
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 4 Aug 2021.