Diarrhoeal diseases

Indications

Gastrointestinal disorders are often characterised by altered bowel activities such as diarrhoea, with or without abdominal pain and increased gas. Of all the symptoms seen in functional gastrointestinal disorders, diarrhoea is the most therapy resistant. Of general importance is information concerning diet and lifestyle. It is important to exclude organic disease when diagnosing functional diarrhoea and the diet should be well balanced as regards nutrients and fat. Diarrhoea can also de caused by an infection of the intestines by virus, bacteria, protozoa or worms. 

IBS (Irritable Bowel Syndrome) is a collective term describing a number of symptoms connected with altered bowel activity that are not necessarily of similar origin or mechanism. One group is non-painful diarrhoea. Even in this case it is important to exclude organic disease. It is not uncommon with functional gastrointestinal disorders in children and adolescents; even colon irritable occurs. 

In bloodstained diarrhoea ulcerative colitis can be assumed, but identification of Crohn’s disease is not as obvious.


Clinical studies

AF treatment of secretory diarrhoea due to carcinoid tumours 

The pathology of diarrhoea in patients with short intestines in most likely due to multiple factors and for this reason it is possible that AF only influences the secretory component of the diarrhoea. Patients with neuroendocrine tumours may suffer from severe diarrhoea, that may be both difficult to treat, treatment resistant and persistent despite an otherwise optimal treatment regime. 

The aim of the study was to investigate if specially processed cereals, SPC-Flakes® or Salovum® could induce AF-activity and if AF-therapy could reduce the number of bowel movements. The treatment with AF products was administered as an additive to the patients’ ongoing medical therapy. 

Eight critically ill patients were included. Six patients with the midgut carcinoid syndrome and two with metastasizing medullary thyroid carcinoma (MTC) participated. In an initial open part of the study all patients received Salovum® for 4 weeks. This was followed by randomisation to a double-blind crossover period with SPC-Flakes® and control cereals without AF inducing ability for 6 weeks in a dose of 1g/kg bodyweight divided into four doses daily. 

Treatment with SPC-Flakes® and Salovum®resulted in a significant reduction of daily bowel movements (Table 1) and several patients reported firmer stools. 

Tabell 1. Number of stools during threatment with cereals

Test period Mean+SD         n p
Baseline 5,6±2,6  7 <0,01
Salovum® 4,2±2,4 7  
Control cereals 4,0±1,9 5 <0,05
SPC-Flakes® 2,6±1,3 5  

All patients had low levels of AF-activity in serum at baseline. During treatment with Salovum®, the mean level increased slightly. AF-activity was also significantly higher after treatment with SPC-Flakes®. In four of the five patients such AF levels in plasma were detected which has in other studies correlated well with positive treatment effects of diarrhoea. 

Although these patients had been given optimal medical therapy, an added positive effect could be seen with the addition of the AF-treatment. Treatment with Salovum® was well tolerated by all patients. The two patients with MTC and fully intact intestines responded best to SPC-diet with the highest AF levels, reaching over 1 unit/ml plasma, after completed treatment. 

The positive response to Salovum® indicates that AF protein has a local effect in the intestine, directly interacting with the receptors and its binding proteins in mucosal cells. Therapy with Salovum® may hence be a suitable treatment alternative for patients with difficulties ingesting large amounts of specially produced cereals.  

Laurenius, Wängberg, Lange, Jennische, Lundgren and Bosaeus, Antisecretory factor counteracts secretory diarrhoea of endocrine origin, Clinical Nutrition, 2003; 22(6):549-542, view link 

Treatment with Salovum® in children with unspecified diarrhoea

A clinical study with Salovum® in Pakistan has also been made in children with severe diarrhoea of acute or prolonged character. 240 children aged 6-24 months were randomised to treatment with 2g Salovum® or placebo in addition to an oral rehydration salt solution every 5 h for three days. In the treatment group with acute diarrhoea (less than 5 days), children treated with Salovum® had a significant improvement of 82,8% compared to 54,4% in the control group (p<0,001). 

Among children with diarrhoea for more than 7 days, the children treated with Salovum had a significant improvement of their condition of 90,9% compared to 63,2% of the controls (p=0,0011). 

The authors conclude that Salovum® is a very appealing treatment option for the future, both in acute and chronic diarrhoea. The optimal dose of Salovum® is not known and because a low dose was used, it is likely that a higher dose in some patients could have given a further improved result. It is also likely that the patients in the study were infected with different agents and it is shown that Salovum® protects against diarrhoeal diseases induced by non-specific nature. 

Salovum® may have a significant impact among populations with a high morbidity and mortality in these diseases. Moreover, it can be followed up with SPC-Flakes® which stimulates the body to produce AF. SPC-Flakes® can also be used for prophylaxis in highly exposed populations, especially during the diarrhoea season. 

Zaman, Mannan, Lange, Lönnroth and Hanson, B221, a medical food containing antisecretory factor reduces child diarrhoea: a placebo controlled trial, Acta Paediatrica Scandinavia 96:1655-1659, 2007, view link  


Expected treatment outcome

A positive treatment effect with Salovum® can normally be seen within a few hours.

After termination of the AF products, a reduced effect can be noticed after a few weeks. If treatment is resumed, AF levels will rise within a matter of days, indicating a biological memory for AF production. 

Salovum® is the recommended AF treatment for patients who have difficulties eating large amounts of SPC-Flakes®. Studies also indicate that patients not responding to treatment with SPC-Flakes® may respond to Salovum®

For seriously ill patients or in patients with suspected low AF-levels, treatment with Salovum® quickly raises AF-levels directly in the intestine. Most often the patients initially treated with Salovum® can thereafter be transferred to the AF-inducing SPC-Flakes® in order to stimulate the body’s own production of AF.


Dosage

The normal dosage of Salovum® is 4 g three times daily. The powder is blended with a cold liquid, e.g juice or water, preferably using a whisk or a blender. 

To stimulate the endogenous production of AF it is favourable to introduce AF inducing cereals, SPC-Flakes®, during treatment with, or as a follow-up treatment towards the end to, Salovum®.


Side effects, interactions and precautions

AF products have been eaten by tens of thousands of individuals and no side effects of medical nature have been reported. A few patients have experienced occasional constipation, but this discomfort can be reduced by a step-by-step introduction of the treatment. 

There are no reported interactions with concomitant medications. This is of importance as the patients should continue with their regular medical treatment. Salovum® should not replace or change the patients’ current medication. Persons with allergy to eggs should not be treated with Salovum®.


Where to buy, Prescriptions

Salovum® can be bought prescription free in pharmacies. As of December 31, 2010, Läkemedelsverket (The Medical Products Agency) has decided to include Salovum® and SPC-Flakes® in the new revised list for food for particular nutritional use for children under 16 years of age  and the cost will thus be included within the national benefit scheme for prescription drugs.

For patients 16 years of age or older, dieticians and most doctors can prescribe Salovum® as “sär-när”, foods for particular nutritional uses certified by the National Food Administration (Livsmedelsverket). The cost of the products varies between the different counties (landsting). 

Sweden: The pharmacies may not have Salovum® in stock, but they can in that case order it within 1-2 days. The reference number (varunummer) for Salovum is 21 06 81 .

Norway: In Norway, both SPC-Flakes® and Salovum® can be prescribed by physicians (blå resept), see links, [http://www.helfo.no/helsepersonell/lege/legemidler/Sider/neringsmidler.aspx] [http://www.legemiddelverket.no/upload/Bl%C3%A5reseptforskriften.pdf]. and link to the Product Catalogue (p 8, Spesialløsninger) [http://www.helfo.no/SiteCollectionDocuments/Vedlegg%20helsepersonell/Grossister%20og%20leverand%C3%B8rer/Produkt-og%20prislister%20fra%2001.07.10/N%C3%A6ringsmidler%2001.07.2010.pdf] Salovum® can also be ordered from Poa Pharma Scandinavia AB, see link  

Denmark: Salovum® can be ordered from Poa Pharma Scandinavia AB, see link  

Finland: Salovum® can be ordered from Poa Pharma Scandinavia AB, see link